Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-03-02 @ 11:11 PM
Study NCT ID:
NCT00576420
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2007-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fibrin Sealant Vascular Surgery Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D026503', 'term': 'Low Density Lipoprotein Receptor-Related Protein-1'}], 'ancestors': [{'id': 'D026502', 'term': 'LDL-Receptor Related Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011973', 'term': 'Receptors, LDL'}, {'id': 'D018110', 'term': 'Receptors, Lipoprotein'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'edith_hantak@baxter.com', 'title': 'Edith Hantak, Dir, Global Therapeutic Area, BioSurgery', 'organization': 'BAXTER INNOVATIONS GmbH'}, 'certainAgreement': {'otherDetails': "Baxter's agreements with PIs may vary per requirements of the individual PI, but contain common elements. For this study, PIs are restricted from independently publishing results until the earlier of the primary multicenter publication or 1 year after study completion. Baxter requires a review of results communications (e.g., for confidential information) ≥45 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Throughout study period (1 year)', 'eventGroups': [{'id': 'EG000', 'title': 'Fibrin Sealant - 60 Seconds', 'description': 'Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time', 'otherNumAtRisk': 26, 'otherNumAffected': 4, 'seriousNumAtRisk': 26, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Fibrin Sealant - 120 Seconds', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization time', 'otherNumAtRisk': 24, 'otherNumAffected': 9, 'seriousNumAtRisk': 24, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Fibrin Sealant All - (60 + 120 Seconds)', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time\n2. FS VH S/D 500 s-apr, 120 seconds polymerization time', 'otherNumAtRisk': 50, 'otherNumAffected': 13, 'seriousNumAtRisk': 50, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Control Group', 'description': 'Treatment of the study-suture line will be manual compression with surgical gauze pads.', 'otherNumAtRisk': 23, 'otherNumAffected': 7, 'seriousNumAtRisk': 23, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Incision site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular graft complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr- 60-Seconds', 'description': 'Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'title': 'Primary Hemostasis Achieved at 4 Minutes', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}, {'value': '62.5', 'groupId': 'OG001'}, {'value': '34.8', 'groupId': 'OG002'}]}]}, {'title': 'Additional Treatment Required for Hemostasis', 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '52.2', 'groupId': 'OG002'}]}]}, {'title': 'Intraoperative Rebleeding After Primary Hemostasis', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '4.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained.\n\nParticipants were considered treatment failures if they met any of the following conditions:\n\n* Did not achieve hemostasis at 4 minutes\n* Required additional hemostatic treatment during the first 4 minutes of the observation period\n* Experienced rebleeding after the first 4 minutes of the observation period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'PRIMARY', 'title': '90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '62.2'}, {'value': '62.5', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '78.8'}, {'value': '34.8', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '51.1'}]}]}], 'analyses': [{'pValue': '0.1564', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '90', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.\n\nParticipants were considered treatment failures if they met any of the following conditions:\n\n* Did not achieve hemostasis at 4 minutes\n* Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period\n* Experienced rebleeding after the first 4 minutes of the observation period.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'PRIMARY', 'title': 'Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '28.0', 'upperLimit': '72.0'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '44.3', 'upperLimit': '89.1'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '16.3', 'upperLimit': '60.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Investigators were shown videos of bleeding severities to standardize assessments.\n\n1. Moderate bleeding defined as:\n\n * Either \\>25% of the suture line bleeds, or\n * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or\n * 1 pulsatile suture line bleeding was present.\n2. Severe bleeding defined as:\n\n * Either \\>50% of the suture line bleeds, or\n * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or\n * \\>1 pulsatile suture line bleeding was present, or\n * ≥1 spurting suture line bleeding was present.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Hemostasis at 6 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '45.8', 'upperLimit': '77.2'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '89.5'}, {'value': '34.8', 'groupId': 'OG002', 'lowerLimit': '18.4', 'upperLimit': '51.1'}]}]}], 'analyses': [{'pValue': '0.060', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 minutes post start of treatment application start', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Hemostasis at 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.4', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '80.7'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '60.5', 'upperLimit': '89.5'}, {'value': '43.5', 'groupId': 'OG002', 'lowerLimit': '26.5', 'upperLimit': '60.5'}]}]}], 'analyses': [{'pValue': '0.123', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '10 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '4.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '11.3'}]}]}], 'analyses': [{'pValue': '0.929', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.228', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Intraoperative day 0', 'description': 'Intraoperative rebleeding at the study suture line after occurrence of hemostasis.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '10.0'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '6.0', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'analyses': [{'pValue': '0.257', 'groupIds': ['OG000', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.096', 'groupIds': ['OG001', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.127', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 (procedure day) through day 30 ± 5', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S -Apr - 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S -Apr - 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)'}, {'id': 'OG002', 'title': 'FS VH S/D 500 S-apr - All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '137.5', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '182.0'}, {'value': '142.5', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '208.0'}, {'value': '141.5', 'groupId': 'OG002', 'lowerLimit': '95.0', 'upperLimit': '208.0'}, {'value': '150.0', 'groupId': 'OG003', 'lowerLimit': '91.0', 'upperLimit': '194.0'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '71.0', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '100.0'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '137.0'}, {'value': '72.0', 'groupId': 'OG002', 'lowerLimit': '46.0', 'upperLimit': '137.0'}, {'value': '78.0', 'groupId': 'OG003', 'lowerLimit': '48.0', 'upperLimit': '111.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to date of surgery', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '47', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr (FS), 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline - Intraoperative Day 0', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline - Intraoperative Day 0', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Preoperative Baseline - Postoperative Day 1', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Preoperative Baseline - Postoperative Day 1', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG008', 'title': 'FS 60: Preoperative Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG009', 'title': 'FS 120: Preoperative Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG010', 'title': 'FS All: Preoperative Baseline - Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG011', 'title': 'Control Group: Preoperative Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '-10.1', 'groupId': 'OG000', 'lowerLimit': '-36.8', 'upperLimit': '21.4'}, {'value': '-6.5', 'groupId': 'OG001', 'lowerLimit': '-42.2', 'upperLimit': '44.4'}, {'value': '-9.8', 'groupId': 'OG002', 'lowerLimit': '-42.2', 'upperLimit': '44.4'}, {'value': '-17.2', 'groupId': 'OG003', 'lowerLimit': '-51.5', 'upperLimit': '15.4'}, {'value': '-6.4', 'groupId': 'OG004', 'lowerLimit': '-34.7', 'upperLimit': '54.1'}, {'value': '-12.4', 'groupId': 'OG005', 'lowerLimit': '-47.1', 'upperLimit': '62.5'}, {'value': '-7.9', 'groupId': 'OG006', 'lowerLimit': '-47.1', 'upperLimit': '62.5'}, {'value': '-11.0', 'groupId': 'OG007', 'lowerLimit': '-29.5', 'upperLimit': '44.4'}, {'value': '-3.8', 'groupId': 'OG008', 'lowerLimit': '-29.7', 'upperLimit': '46.9'}, {'value': '-3.7', 'groupId': 'OG009', 'lowerLimit': '-47.1', 'upperLimit': '50.9'}, {'value': '-3.8', 'groupId': 'OG010', 'lowerLimit': '-47.1', 'upperLimit': '50.9'}, {'value': '-6.6', 'groupId': 'OG011', 'lowerLimit': '-33.5', 'upperLimit': '10.0'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '-8.2', 'groupId': 'OG000', 'lowerLimit': '-66.7', 'upperLimit': '100.0'}, {'value': '-16.4', 'groupId': 'OG001', 'lowerLimit': '-64.6', 'upperLimit': '36.5'}, {'value': '-11.4', 'groupId': 'OG002', 'lowerLimit': '-66.7', 'upperLimit': '100.0'}, {'value': '-21.9', 'groupId': 'OG003', 'lowerLimit': '-45.0', 'upperLimit': '41.7'}, {'value': '-1.5', 'groupId': 'OG004', 'lowerLimit': '-38.5', 'upperLimit': '63.0'}, {'value': '-19.4', 'groupId': 'OG005', 'lowerLimit': '-60.6', 'upperLimit': '40.0'}, {'value': '-7.5', 'groupId': 'OG006', 'lowerLimit': '-60.6', 'upperLimit': '63.0'}, {'value': '-9.6', 'groupId': 'OG007', 'lowerLimit': '-39.4', 'upperLimit': '13.8'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '-28.6', 'upperLimit': '36.7'}, {'value': '-7.5', 'groupId': 'OG009', 'lowerLimit': '-48.9', 'upperLimit': '51.9'}, {'value': '-1.1', 'groupId': 'OG010', 'lowerLimit': '-48.9', 'upperLimit': '51.9'}, {'value': '-7.1', 'groupId': 'OG011', 'lowerLimit': '-37.5', 'upperLimit': '39.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Heart Rate - Preoperative Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):\n\n1. 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '139.0'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '53.0', 'upperLimit': '98.0'}, {'value': '72.0', 'groupId': 'OG002', 'lowerLimit': '50.0', 'upperLimit': '139.0'}, {'value': '74.0', 'groupId': 'OG003', 'lowerLimit': '57.0', 'upperLimit': '112.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to date of surgery', 'unitOfMeasure': 'Heart beats/ minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent Change in Vital Signs: Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}, {'value': '50', 'groupId': 'OG006'}, {'value': '23', 'groupId': 'OG007'}, {'value': '25', 'groupId': 'OG008'}, {'value': '22', 'groupId': 'OG009'}, {'value': '47', 'groupId': 'OG010'}, {'value': '20', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline - Intraoperative Day 0', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline - Intraoperative Day 0', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Preoperative Baseline - Postoperative Day 1', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Preoperative Baseline - Postoperative Day 1', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG008', 'title': 'FS 60: Preoperative Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG009', 'title': 'FS 120: Preoperative Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG010', 'title': 'FS All: Preoperative Baseline - Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG011', 'title': 'Control Group: Preoperative Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.0', 'groupId': 'OG000', 'lowerLimit': '-58.3', 'upperLimit': '38.6'}, {'value': '-2.6', 'groupId': 'OG001', 'lowerLimit': '-35.6', 'upperLimit': '37.1'}, {'value': '-6.3', 'groupId': 'OG002', 'lowerLimit': '-58.3', 'upperLimit': '38.6'}, {'value': '-9.5', 'groupId': 'OG003', 'lowerLimit': '-30.8', 'upperLimit': '21.2'}, {'value': '-6.7', 'groupId': 'OG004', 'lowerLimit': '-34.0', 'upperLimit': '27.1'}, {'value': '2.0', 'groupId': 'OG005', 'lowerLimit': '-30.6', 'upperLimit': '32.7'}, {'value': '-1.4', 'groupId': 'OG006', 'lowerLimit': '-34.0', 'upperLimit': '32.7'}, {'value': '9.9', 'groupId': 'OG007', 'lowerLimit': '-24.4', 'upperLimit': '54.5'}, {'value': '3.0', 'groupId': 'OG008', 'lowerLimit': '-19.5', 'upperLimit': '30.6'}, {'value': '7.4', 'groupId': 'OG009', 'lowerLimit': '-30.1', 'upperLimit': '22.9'}, {'value': '4.4', 'groupId': 'OG010', 'lowerLimit': '-30.1', 'upperLimit': '30.6'}, {'value': '1.8', 'groupId': 'OG011', 'lowerLimit': '-26.8', 'upperLimit': '26.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Respiratory Rate - Preoperative Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '24.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '20.0'}, {'value': '18.0', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '24.0'}, {'value': '18.0', 'groupId': 'OG003', 'lowerLimit': '16.0', 'upperLimit': '26.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to date of surgery', 'unitOfMeasure': 'Breaths/ minute', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percent Change in Vital Signs: Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '43', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline - Postoperative Day 1', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Preoperative Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-35.0', 'upperLimit': '33.3'}, {'value': '-10.0', 'groupId': 'OG001', 'lowerLimit': '-30.0', 'upperLimit': '28.6'}, {'value': '-10.0', 'groupId': 'OG002', 'lowerLimit': '-35.0', 'upperLimit': '33.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-23.1', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '-20.0', 'upperLimit': '25.0'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '-29.4', 'upperLimit': '38.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '-29.4', 'upperLimit': '38.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '-46.2', 'upperLimit': '33.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14', 'unitOfMeasure': 'percent change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '12.00', 'groupId': 'OG000', 'lowerLimit': '6.60', 'upperLimit': '16.50'}, {'value': '12.55', 'groupId': 'OG001', 'lowerLimit': '9.00', 'upperLimit': '16.60'}, {'value': '12.25', 'groupId': 'OG002', 'lowerLimit': '6.60', 'upperLimit': '16.60'}, {'value': '12.15', 'groupId': 'OG003', 'lowerLimit': '10.10', 'upperLimit': '14.70'}, {'value': '11.15', 'groupId': 'OG004', 'lowerLimit': '7.60', 'upperLimit': '16.10'}, {'value': '12.40', 'groupId': 'OG005', 'lowerLimit': '8.30', 'upperLimit': '14.40'}, {'value': '12.05', 'groupId': 'OG006', 'lowerLimit': '7.60', 'upperLimit': '16.10'}, {'value': '11.70', 'groupId': 'OG007', 'lowerLimit': '8.50', 'upperLimit': '13.60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '37.00', 'groupId': 'OG000', 'lowerLimit': '23.00', 'upperLimit': '47.00'}, {'value': '37.00', 'groupId': 'OG001', 'lowerLimit': '30.00', 'upperLimit': '51.00'}, {'value': '37.00', 'groupId': 'OG002', 'lowerLimit': '23.00', 'upperLimit': '51.00'}, {'value': '39.00', 'groupId': 'OG003', 'lowerLimit': '30.00', 'upperLimit': '45.00'}, {'value': '35.00', 'groupId': 'OG004', 'lowerLimit': '26.00', 'upperLimit': '48.00'}, {'value': '38.00', 'groupId': 'OG005', 'lowerLimit': '28.00', 'upperLimit': '47.00'}, {'value': '37.00', 'groupId': 'OG006', 'lowerLimit': '26.00', 'upperLimit': '48.00'}, {'value': '36.50', 'groupId': 'OG007', 'lowerLimit': '27.00', 'upperLimit': '41.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'percentage of red blood cells in blood', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '46', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. 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FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '6.31', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '16.22'}, {'value': '7.14', 'groupId': 'OG001', 'lowerLimit': '3.45', 'upperLimit': '15.16'}, {'value': '6.62', 'groupId': 'OG002', 'lowerLimit': '2.48', 'upperLimit': '16.22'}, {'value': '7.98', 'groupId': 'OG003', 'lowerLimit': '3.62', 'upperLimit': '13.76'}, {'value': '6.58', 'groupId': 'OG004', 'lowerLimit': '3.34', 'upperLimit': '14.12'}, {'value': '7.87', 'groupId': 'OG005', 'lowerLimit': '4.36', 'upperLimit': '16.89'}, {'value': '7.00', 'groupId': 'OG006', 'lowerLimit': '3.34', 'upperLimit': '16.89'}, {'value': '8.13', 'groupId': 'OG007', 'lowerLimit': '6.25', 'upperLimit': '18.62'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': 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'0.51', 'upperLimit': '4.59'}, {'value': '1.94', 'groupId': 'OG007', 'lowerLimit': '0.86', 'upperLimit': '3.82'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '3.70', 'groupId': 'OG000', 'lowerLimit': '1.59', 'upperLimit': '12.55'}, {'value': '4.69', 'groupId': 'OG001', 'lowerLimit': '2.22', 'upperLimit': '13.70'}, {'value': '4.11', 'groupId': 'OG002', 'lowerLimit': '1.59', 'upperLimit': '13.70'}, {'value': '5.24', 'groupId': 'OG003', 'lowerLimit': '2.17', 'upperLimit': '8.67'}, {'value': '4.44', 'groupId': 'OG004', 'lowerLimit': '2.38', 'upperLimit': '9.92'}, {'value': '5.23', 'groupId': 'OG005', 'lowerLimit': '2.72', 'upperLimit': '15.38'}, {'value': '4.66', 'groupId': 'OG006', 'lowerLimit': '2.38', 'upperLimit': '15.38'}, {'value': '5.54', 'groupId': 'OG007', 'lowerLimit': '3.81', 'upperLimit': '14.64'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '0.72'}, {'value': '0.41', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '0.82'}, {'value': '0.36', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '0.82'}, {'value': '0.39', 'groupId': 'OG003', 'lowerLimit': '0.18', 'upperLimit': '0.83'}, {'value': '0.35', 'groupId': 'OG004', 'lowerLimit': '0.22', 'upperLimit': '0.58'}, {'value': '0.43', 'groupId': 'OG005', 'lowerLimit': '0.22', 'upperLimit': '0.77'}, {'value': '0.38', 'groupId': 'OG006', 'lowerLimit': '0.22', 'upperLimit': '0.77'}, {'value': '0.44', 'groupId': 'OG007', 'lowerLimit': '0.13', 'upperLimit': '0.57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'x10^3/µl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '44', 'groupId': 'OG006'}, {'value': '16', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '184.00', 'groupId': 'OG000', 'lowerLimit': '70.00', 'upperLimit': '423.00'}, {'value': '204.00', 'groupId': 'OG001', 'lowerLimit': '56.00', 'upperLimit': '442.00'}, {'value': '195.50', 'groupId': 'OG002', 'lowerLimit': '56.00', 'upperLimit': '442.00'}, {'value': '233.00', 'groupId': 'OG003', 'lowerLimit': '132.00', 'upperLimit': '462.00'}, {'value': '226.00', 'groupId': 'OG004', 'lowerLimit': '138.00', 'upperLimit': '538.00'}, {'value': '333.00', 'groupId': 'OG005', 'lowerLimit': '117.00', 'upperLimit': '593.00'}, {'value': '275.00', 'groupId': 'OG006', 'lowerLimit': '117.00', 'upperLimit': '593.00'}, {'value': '295.00', 'groupId': 'OG007', 'lowerLimit': '199.00', 'upperLimit': '386.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'x10^3/µl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Creatinine', 'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '13.80'}, {'value': '1.90', 'groupId': 'OG001', 'lowerLimit': '0.60', 'upperLimit': '13.30'}, {'value': '3.50', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '13.80'}, {'value': '2.65', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '9.40'}, {'value': '4.60', 'groupId': 'OG004', 'lowerLimit': '0.60', 'upperLimit': '12.70'}, {'value': '2.40', 'groupId': 'OG005', 'lowerLimit': '0.60', 'upperLimit': '12.70'}, {'value': '3.50', 'groupId': 'OG006', 'lowerLimit': '0.60', 'upperLimit': '12.70'}, {'value': '3.25', 'groupId': 'OG007', 'lowerLimit': '0.50', 'upperLimit': '11.00'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '0.20', 'upperLimit': '1.00'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.20', 'upperLimit': '1.10'}, {'value': '0.30', 'groupId': 'OG002', 'lowerLimit': '0.20', 'upperLimit': '1.10'}, {'value': '0.40', 'groupId': 'OG003', 'lowerLimit': '0.20', 'upperLimit': '0.70'}, {'value': '0.30', 'groupId': 'OG004', 'lowerLimit': '0.20', 'upperLimit': '3.30'}, {'value': '0.40', 'groupId': 'OG005', 'lowerLimit': '0.20', 'upperLimit': '0.70'}, {'value': '0.30', 'groupId': 'OG006', 'lowerLimit': '0.20', 'upperLimit': '3.30'}, {'value': '0.30', 'groupId': 'OG007', 'lowerLimit': '0.20', 'upperLimit': '0.60'}]}]}, {'title': 'BUN', 'categories': [{'measurements': [{'value': '24.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '104.00'}, {'value': '31.00', 'groupId': 'OG001', 'lowerLimit': '8.00', 'upperLimit': '122.00'}, {'value': '26.00', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '122.00'}, {'value': '29.00', 'groupId': 'OG003', 'lowerLimit': '9.00', 'upperLimit': '73.00'}, {'value': '30.00', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '72.00'}, {'value': '26.00', 'groupId': 'OG005', 'lowerLimit': '8.00', 'upperLimit': '125.00'}, {'value': '27.00', 'groupId': 'OG006', 'lowerLimit': '4.00', 'upperLimit': '125.00'}, {'value': '27.00', 'groupId': 'OG007', 'lowerLimit': '6.00', 'upperLimit': '84.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '16.00', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '47.00'}, {'value': '17.00', 'groupId': 'OG001', 'lowerLimit': '7.00', 'upperLimit': '43.00'}, {'value': '16.00', 'groupId': 'OG002', 'lowerLimit': '4.00', 'upperLimit': '47.00'}, {'value': '16.50', 'groupId': 'OG003', 'lowerLimit': '7.00', 'upperLimit': '29.00'}, {'value': '12.00', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '32.00'}, {'value': '15.00', 'groupId': 'OG005', 'lowerLimit': '4.00', 'upperLimit': '39.00'}, {'value': '14.00', 'groupId': 'OG006', 'lowerLimit': '4.00', 'upperLimit': '39.00'}, {'value': '12.00', 'groupId': 'OG007', 'lowerLimit': '4.00', 'upperLimit': '20.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '45', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '18.00', 'groupId': 'OG000', 'lowerLimit': '14.00', 'upperLimit': '51.00'}, {'value': '19.00', 'groupId': 'OG001', 'lowerLimit': '11.00', 'upperLimit': '45.00'}, {'value': '18.00', 'groupId': 'OG002', 'lowerLimit': '11.00', 'upperLimit': '51.00'}, {'value': '16.00', 'groupId': 'OG003', 'lowerLimit': '12.00', 'upperLimit': '44.00'}, {'value': '18.00', 'groupId': 'OG004', 'lowerLimit': '13.00', 'upperLimit': '29.00'}, {'value': '20.00', 'groupId': 'OG005', 'lowerLimit': '7.00', 'upperLimit': '39.00'}, {'value': '19.00', 'groupId': 'OG006', 'lowerLimit': '7.00', 'upperLimit': '39.00'}, {'value': '17.50', 'groupId': 'OG007', 'lowerLimit': '11.00', 'upperLimit': '30.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '42', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '25.10', 'groupId': 'OG000', 'lowerLimit': '19.60', 'upperLimit': '109.80'}, {'value': '26.30', 'groupId': 'OG001', 'lowerLimit': '21.60', 'upperLimit': '51.00'}, {'value': '25.90', 'groupId': 'OG002', 'lowerLimit': '19.60', 'upperLimit': '109.80'}, {'value': '25.10', 'groupId': 'OG003', 'lowerLimit': '19.90', 'upperLimit': '150.00'}, {'value': '24.65', 'groupId': 'OG004', 'lowerLimit': '20.30', 'upperLimit': '150.00'}, {'value': '27.20', 'groupId': 'OG005', 'lowerLimit': '20.10', 'upperLimit': '150.00'}, {'value': '25.00', 'groupId': 'OG006', 'lowerLimit': '20.10', 'upperLimit': '150.00'}, {'value': '26.75', 'groupId': 'OG007', 'lowerLimit': '20.40', 'upperLimit': '150.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: International Normalized Ratio (INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}, {'value': '41', 'groupId': 'OG006'}, {'value': '18', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'FS 60: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG001', 'title': 'FS 120: Preoperative Baseline', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG002', 'title': 'FS All: Preoperative Baseline', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG003', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG004', 'title': 'FS 60: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization'}, {'id': 'OG005', 'title': 'FS 120: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization'}, {'id': 'OG006', 'title': 'FS All: Postoperative Day 14', 'description': 'All study participants who received Fibrin Sealant (60 + 120 Seconds):\n\n1. Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time\n2. FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG007', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '1.20'}, {'value': '1.10', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '2.40'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.90', 'upperLimit': '2.40'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '0.90', 'upperLimit': '1.20'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.90', 'upperLimit': '2.10'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '0.90', 'upperLimit': '3.20'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '0.90', 'upperLimit': '3.20'}, {'value': '1.00', 'groupId': 'OG007', 'lowerLimit': '0.90', 'upperLimit': '4.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'PRIMARY', 'title': 'Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr - 60-Seconds', 'description': 'FS VH S/D 500 s-apr, 60-seconds polymerization time'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr, 120-seconds polymerization time'}, {'id': 'OG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '65.1'}, {'value': '58.3', 'groupId': 'OG001', 'lowerLimit': '34.9', 'upperLimit': '81.7'}, {'value': '30.0', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '53.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Investigators were shown videos of bleeding severities to standardize assessments.\n\nSevere bleeding defined as:\n\n* Either \\>50% of the suture line bleeds, or\n* ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or\n* \\>1 pulsatile suture line bleeding was present, or\n* ≥1 spurting suture line bleeding was present.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FS VH S/D 500 S-apr - 60 Seconds', 'description': 'Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time'}, {'id': 'FG001', 'title': 'FS VH S/D 500 S-apr - 120 Seconds', 'description': 'FS VH S/D 500 s-apr, 120 - seconds polymerization time'}, {'id': 'FG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 12 clinical sites in the United States, beginning December 2007. The last participant completed the study in December 2008', 'preAssignmentDetails': '101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'FS VH S/D 500 S-apr - 60 Seconds', 'description': 'FS VH S/D 500 s-apr, 60 - seconds polymerization time'}, {'id': 'BG001', 'title': 'FS VH S/D 500 S-apr - 120 Seconds', 'description': 'FS VH S/D 500 s-apr, 120 - seconds polymerization time'}, {'id': 'BG002', 'title': 'Control Group', 'description': 'Manual compression with surgical gauze pads.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '12.7', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '85'}, {'value': '67.0', 'spread': '14.6', 'groupId': 'BG001', 'lowerLimit': '24', 'upperLimit': '84'}, {'value': '63.0', 'spread': '14.4', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '86'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'dispFirstSubmitDate': '2010-01-13', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2007-12-18', 'dispFirstSubmitQcDate': '2010-01-13', 'resultsFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2007-12-18', 'dispFirstPostDateStruct': {'date': '2010-01-18', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-26', 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained.\n\nParticipants were considered treatment failures if they met any of the following conditions:\n\n* Did not achieve hemostasis at 4 minutes\n* Required additional hemostatic treatment during the first 4 minutes of the observation period\n* Experienced rebleeding after the first 4 minutes of the observation period.'}, {'measure': '90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.\n\nParticipants were considered treatment failures if they met any of the following conditions:\n\n* Did not achieve hemostasis at 4 minutes\n* Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period\n* Experienced rebleeding after the first 4 minutes of the observation period.'}, {'measure': 'Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Investigators were shown videos of bleeding severities to standardize assessments.\n\n1. Moderate bleeding defined as:\n\n * Either \\>25% of the suture line bleeds, or\n * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or\n * 1 pulsatile suture line bleeding was present.\n2. Severe bleeding defined as:\n\n * Either \\>50% of the suture line bleeds, or\n * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or\n * \\>1 pulsatile suture line bleeding was present, or\n * ≥1 spurting suture line bleeding was present.'}, {'measure': 'Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Investigators were shown videos of bleeding severities to standardize assessments.\n\nSevere bleeding defined as:\n\n* Either \\>50% of the suture line bleeds, or\n* ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or\n* \\>1 pulsatile suture line bleeding was present, or\n* ≥1 spurting suture line bleeding was present.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Hemostasis at 6 Minutes', 'timeFrame': '6 minutes post start of treatment application start', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.'}, {'measure': 'Percentage of Participants Achieving Hemostasis at 10 Minutes', 'timeFrame': '10 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.'}, {'measure': 'Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line', 'timeFrame': 'Intraoperative day 0', 'description': 'Intraoperative rebleeding at the study suture line after occurrence of hemostasis.'}, {'measure': 'Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line', 'timeFrame': 'Postoperative through day 30 ± 5', 'description': 'Any rebleeding requiring surgical reexploration'}, {'measure': 'Percentage of Participants With Any Transfusion Requirement', 'timeFrame': 'Intraoperative (day 0) through day 30 ± 5', 'description': 'Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)'}, {'measure': 'Percentage of Participants With Graft Occlusions', 'timeFrame': 'Day 0 (procedure day) through day 30 ± 5', 'description': 'Determined clinically and defined as absence of blood flow through the graft.'}, {'measure': 'Percentage of Participants With Infections at the Surgical Site', 'timeFrame': 'Day 0 (procedure day) through day 30 ± 5'}, {'measure': 'Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline', 'timeFrame': 'Within 14 days prior to date of surgery'}, {'measure': 'Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14'}, {'measure': 'Vital Signs: Heart Rate - Preoperative Baseline', 'timeFrame': 'Within 14 days prior to date of surgery'}, {'measure': 'Percent Change in Vital Signs: Heart Rate', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14'}, {'measure': 'Vital Signs: Respiratory Rate - Preoperative Baseline', 'timeFrame': 'Within 14 days prior to date of surgery'}, {'measure': 'Percent Change in Vital Signs: Respiratory Rate', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'description': 'Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Hemoglobin', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Hematocrit', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Erythrocytes', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Platelets', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Alanine Aminotransferase (ALT)', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Aspartate Aminotransferase (AST)', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}, {'measure': 'Laboratory Values Over Time: International Normalized Ratio (INR)', 'timeFrame': 'Preoperative baseline through postoperative Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)']}, 'referencesModule': {'references': [{'pmid': '21514114', 'type': 'RESULT', 'citation': 'Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of all ages\n* Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses \\[including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass\\], or arteriovenous dialysis access shunt in the upper or lower extremity.\n* Signed informed consent\n\nIntraoperative inclusion criterion:\n\n\\- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).\n\nSuture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)\n\nNote: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.\n\nExclusion Criteria:\n\n* Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days\n* Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)\n* Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)\n* Pregnant or lactating women\n* Congenital coagulation disorders\n* Prior kidney transplantation\n* Heparin-induced thrombocytopenia\n* Known prior exposure to aprotinin within the last 12 months\n* Known hypersensitivity to aprotinin or other components of the product\n* Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)\n* Prior radiation therapy to the operating field\n* Severe local inflammation at the operating field.\n\nIntraoperative exclusion criterion:\n\n* Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.\n* Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (e.g. abandonment of ePTFE graft placement).'}, 'identificationModule': {'nctId': 'NCT00576420', 'briefTitle': 'Fibrin Sealant Vascular Surgery Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery', 'orgStudyIdInfo': {'id': '550602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FS VH S/D 500 s-apr - 60-Seconds', 'description': 'Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time', 'interventionNames': ['Biological: FS VH S/D 500 s-apr, 60-seconds polymerization time']}, {'type': 'EXPERIMENTAL', 'label': 'FS VH S/D 500 s-apr - 120-Seconds', 'description': 'FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time', 'interventionNames': ['Biological: FS VH S/D 500 s-apr, 120-seconds polymerization time']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group- Manual compression with surgical gauze pads', 'description': 'Treatment of the study-suture line will be manual compression with surgical gauze pads.', 'interventionNames': ['Procedure: Manual compression with surgical gauze pads']}], 'interventions': [{'name': 'FS VH S/D 500 s-apr, 60-seconds polymerization time', 'type': 'BIOLOGICAL', 'description': 'FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.', 'armGroupLabels': ['FS VH S/D 500 s-apr - 60-Seconds']}, {'name': 'FS VH S/D 500 s-apr, 120-seconds polymerization time', 'type': 'BIOLOGICAL', 'description': 'Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.', 'armGroupLabels': ['FS VH S/D 500 s-apr - 120-Seconds']}, {'name': 'Manual compression with surgical gauze pads', 'type': 'PROCEDURE', 'description': 'Treatment of the study suture line with manual compression with surgical gauze pads.', 'armGroupLabels': ['Control Group- Manual compression with surgical gauze pads']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}