Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-26 @ 10:36 PM
Study NCT ID:
NCT00892957
Status:
COMPLETED
Last Update Posted:
2012-11-27
First Post:
2009-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
FS VH S/D 500 S-apr in Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015718', 'term': 'Fibrin Tissue Adhesive'}, {'id': 'D012997', 'term': 'Solvents'}, {'id': 'D013917', 'term': 'Thrombin'}, {'id': 'D026503', 'term': 'Low Density Lipoprotein Receptor-Related Protein-1'}], 'ancestors': [{'id': 'D005337', 'term': 'Fibrin'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D026502', 'term': 'LDL-Receptor Related 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) ≥90 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 the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.', 'eventGroups': [{'id': 'EG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr will be applied to the study suture line.', 'otherNumAtRisk': 70, 'otherNumAffected': 14, 'seriousNumAtRisk': 70, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Control - Manual Compression With Surgical Gauze Pads', 'description': 'Dry gauze pads will be positioned to cover the complete study suture line.', 'otherNumAtRisk': 70, 'otherNumAffected': 7, 'seriousNumAtRisk': 70, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Operative haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vascular graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ischaemic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Steal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Graft thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '51.2', 'upperLimit': '73.6'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '42.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', '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.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Hemostasis at 6 Minutes Post Treatment Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '60.2', 'upperLimit': '81.1'}, {'value': '42.9', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '54.6'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'groupId': 'OG000', 'lowerLimit': '64.9', 'upperLimit': '84.7'}, {'value': '55.7', 'groupId': 'OG001', 'lowerLimit': '44.0', 'upperLimit': '67.0'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', '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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '12.8'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '6.1'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', '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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Postoperative Rebleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '5.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Postoperative through day 30 ± 5', 'description': 'Any rebleeding requiring surgical re-exploration', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Graft Occlusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '14.7'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '5.4', 'upperLimit': '20.2'}]}]}], 'analyses': [{'pValue': '0.380', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30', 'description': 'Determined clinically and defined as absence of blood flow through the graft.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Infection at the Surgical Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '18.4'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '14.7'}]}]}], 'analyses': [{'pValue': '0.545', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Likelihood ratio chi-square test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infections by Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'title': 'Grade I', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade II', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade III', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30', 'description': 'Infections were recorded according to:\n\n* Grade I: only dermis affected\n* Grade II: infection invades subcutaneous region but not the arterial implant\n* Grade III: the arterial implant is infected', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'title': 'Systolic blood pressure', 'categories': [{'measurements': [{'value': '139.5', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '197'}, {'value': '143.5', 'groupId': 'OG001', 'lowerLimit': '90', 'upperLimit': '215'}]}]}, {'title': 'Diastolic blood pressure', 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '104'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '113'}]}]}], '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': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control: Preop Baseline - Intraoperative Day 0', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}, {'id': 'OG002', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG003', 'title': 'Control: Preop Baseline - Postoperative Day 1', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}, {'id': 'OG004', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG005', 'title': 'Control: Preop Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'title': 'Systolic BP', 'categories': [{'measurements': [{'value': '-15.63', 'groupId': 'OG000', 'lowerLimit': '-52.5', 'upperLimit': '44.2'}, {'value': '-12.46', 'groupId': 'OG001', 'lowerLimit': '-52.1', 'upperLimit': '74.3'}, {'value': '-8.33', 'groupId': 'OG002', 'lowerLimit': '-45.5', 'upperLimit': '34.9'}, {'value': '-7.72', 'groupId': 'OG003', 'lowerLimit': '-40.5', 'upperLimit': '52.7'}, {'value': '-2.59', 'groupId': 'OG004', 'lowerLimit': '-40.5', 'upperLimit': '35.7'}, {'value': '-2.94', 'groupId': 'OG005', 'lowerLimit': '-39.5', 'upperLimit': '68.9'}]}]}, {'title': 'Diastolic BP (Control Postoperative Day 14 N=64)', 'categories': [{'measurements': [{'value': '-17.29', 'groupId': 'OG000', 'lowerLimit': '-52.9', 'upperLimit': '50.0'}, {'value': '-16.87', 'groupId': 'OG001', 'lowerLimit': '-49.5', 'upperLimit': '33.9'}, {'value': '-11.58', 'groupId': 'OG002', 'lowerLimit': '-49.4', 'upperLimit': '55.3'}, {'value': '-16.84', 'groupId': 'OG003', 'lowerLimit': '-56.6', 'upperLimit': '32.8'}, {'value': '-2.64', 'groupId': 'OG004', 'lowerLimit': '-40.2', 'upperLimit': '58.2'}, {'value': '-7.30', 'groupId': 'OG005', 'lowerLimit': '-50.5', 'upperLimit': '41.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to surgery 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': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '52', 'upperLimit': '106'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '105'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to date of surgery', 'unitOfMeasure': 'beats per 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': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '70', 'groupId': 'OG003'}, {'value': '68', 'groupId': 'OG004'}, {'value': '65', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control: Preop Baseline - Intraoperative Day 0', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}, {'id': 'OG002', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG003', 'title': 'Control: Preop Baseline - Postoperative Day 1', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}, {'id': 'OG004', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG005', 'title': 'Control: Preop Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.27', 'groupId': 'OG000', 'lowerLimit': '-34.2', 'upperLimit': '32.4'}, {'value': '-2.12', 'groupId': 'OG001', 'lowerLimit': '-37.5', 'upperLimit': '123.8'}, {'value': '5.44', 'groupId': 'OG002', 'lowerLimit': '-22.9', 'upperLimit': '82.8'}, {'value': '4.84', 'groupId': 'OG003', 'lowerLimit': '-36.5', 'upperLimit': '84.0'}, {'value': '5.63', 'groupId': 'OG004', 'lowerLimit': '-20.0', 'upperLimit': '79.3'}, {'value': '0.00', 'groupId': 'OG005', 'lowerLimit': '-23.8', 'upperLimit': '81.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to surgery 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': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '22'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to date of surgery', 'unitOfMeasure': 'breaths per 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': '65', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control: Preop Baseline - Postoperative Day 1', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}, {'id': 'OG002', 'title': 'FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG003', 'title': 'Control: Preop Baseline - Postoperative Day 14', 'description': 'Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.00', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '66.7'}, {'value': '-9.55', 'groupId': 'OG001', 'lowerLimit': '-40.0', 'upperLimit': '42.9'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-40.0', 'upperLimit': '55.6'}, {'value': '-6.07', 'groupId': 'OG003', 'lowerLimit': '-40.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 14 days prior to surgery through postoperative day 14', 'description': 'Percent Change in Heart Rate Measured as: 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': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '12.10', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '15.4'}, {'value': '11.60', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '14.5'}, {'value': '12.20', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '18.4'}, {'value': '11.80', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '15.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '50'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '46'}, {'value': '38.5', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '58'}, {'value': '37.0', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '49'}]}]}], '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 Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Erythrocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '4.20', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '5.3'}, {'value': '3.90', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.0'}, {'value': '4.10', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '5.8'}, {'value': '3.90', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'x10^6/µl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Leukocytes', 'categories': [{'measurements': [{'value': '7.105', 'groupId': 'OG000', 'lowerLimit': '2.46', 'upperLimit': '14.83'}, {'value': '8.260', 'groupId': 'OG001', 'lowerLimit': '3.85', 'upperLimit': '14.16'}, {'value': '6.760', 'groupId': 'OG002', 'lowerLimit': '2.93', 'upperLimit': '15.00'}, {'value': '7.980', 'groupId': 'OG003', 'lowerLimit': '3.51', 'upperLimit': '13.76'}]}]}, {'title': 'Basophils', 'categories': [{'measurements': [{'value': '0.040', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.11'}, {'value': '0.040', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.11'}, {'value': '0.040', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '0.20'}, {'value': '0.050', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.16'}]}]}, {'title': 'Eosinophils', 'categories': [{'measurements': [{'value': '0.180', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.96'}, {'value': '0.200', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.81'}, {'value': '0.160', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.61'}, {'value': '0.220', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.79'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '1.805', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '4.55'}, {'value': '1.800', 'groupId': 'OG001', 'lowerLimit': '0.29', 'upperLimit': '3.74'}, {'value': '1.700', 'groupId': 'OG002', 'lowerLimit': '0.54', 'upperLimit': '4.61'}, {'value': '1.750', 'groupId': 'OG003', 'lowerLimit': '0.69', 'upperLimit': '4.27'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '4.585', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '11.30'}, {'value': '5.570', 'groupId': 'OG001', 'lowerLimit': '2.50', 'upperLimit': '11.04'}, {'value': '4.560', 'groupId': 'OG002', 'lowerLimit': '1.32', 'upperLimit': '12.19'}, {'value': '5.150', 'groupId': 'OG003', 'lowerLimit': '2.02', 'upperLimit': '10.37'}]}]}, {'title': 'Monocytes', 'categories': [{'measurements': [{'value': '0.370', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '1.02'}, {'value': '0.430', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '1.17'}, {'value': '0.400', 'groupId': 'OG002', 'lowerLimit': '0.15', 'upperLimit': '0.98'}, {'value': '0.460', 'groupId': 'OG003', 'lowerLimit': '0.13', 'upperLimit': '1.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'x10^3/µl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '227.0', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '562'}, {'value': '303.0', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '643'}, {'value': '239.0', 'groupId': 'OG002', 'lowerLimit': '66', 'upperLimit': '646'}, {'value': '283.0', 'groupId': 'OG003', 'lowerLimit': '116', 'upperLimit': '661'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'x10^3/µl', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'title': 'Creatinine', 'categories': [{'measurements': [{'value': '1.80', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '13.1'}, {'value': '2.20', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '11.1'}, {'value': '2.90', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '12.4'}, {'value': '4.40', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '10.0'}]}]}, {'title': 'Bilirubin', 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.30', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.2'}, {'value': '0.30', 'groupId': 'OG002', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '0.30', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '1.3'}]}]}, {'title': 'BUN', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '76'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '77'}, {'value': '22.0', 'groupId': 'OG002', 'lowerLimit': '7', 'upperLimit': '111'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '6', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Alanine Aminotransferase (ALT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '152'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '95'}, {'value': '14.0', 'groupId': 'OG002', 'lowerLimit': '4', 'upperLimit': '69'}, {'value': '13.0', 'groupId': 'OG003', 'lowerLimit': '4', 'upperLimit': '99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Aspartate Aminotransferase (AST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '61'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '81'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '8', 'upperLimit': '92'}, {'value': '20.0', 'groupId': 'OG003', 'lowerLimit': '10', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '24.40', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '150.0'}, {'value': '25.10', 'groupId': 'OG001', 'lowerLimit': '18.0', 'upperLimit': '150.0'}, {'value': '25.20', 'groupId': 'OG002', 'lowerLimit': '18.2', 'upperLimit': '150.0'}, {'value': '25.80', 'groupId': 'OG003', 'lowerLimit': '19.3', 'upperLimit': '150.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'SECONDARY', 'title': 'Laboratory Values Over Time: International Normalized Ratio(INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '59', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr: Baseline', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG001', 'title': 'FS VH S/D 500 S-apr: Postoperative Day 14', 'description': 'FS VH S/D 500 s-apr, 120 seconds polymerization'}, {'id': 'OG002', 'title': 'Control Group: Preoperative Baseline', 'description': 'Manual compression with surgical gauze pads'}, {'id': 'OG003', 'title': 'Control Group: Postoperative Day 14', 'description': 'Manual compression with surgical gauze pads'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '3.6'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '4.1'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.9', 'upperLimit': '1.5'}, {'value': '1.00', 'groupId': 'OG003', 'lowerLimit': '0.9', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Preoperative baseline through postoperative Day 14', 'unitOfMeasure': 'ratio', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Data Set'}, {'type': 'PRIMARY', 'title': 'Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000', 'lowerLimit': '58.5', 'upperLimit': '88.8'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '66.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Investigators were shown videos of bleeding severities to standardize assessments.\n\nModerate 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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% 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 - Severe Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr was applied to the study suture line'}, {'id': 'OG001', 'title': 'Control - Manual Compression With Surgical Gauze', 'description': 'Dry gauze pads were positioned to cover the complete study suture line'}], 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '68.4'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '34.6'}]}]}], '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': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr will be applied to the study suture line.'}, {'id': 'FG001', 'title': 'Control - Manual Compression With Surgical Gauze Pads', 'description': 'Dry gauze pads will be positioned to cover the complete study suture line.'}], 'periods': [{'title': 'Intraoperative Day 0', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Postoperative Day 1 Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Between Postoperative Day 1 and Day 14', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}, {'title': 'Postoperative Day 14 Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two participants missed postoperative Day 14 assessment, both returned for Day 30 postop assessment', 'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Postoperative Day 30 Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two participants missed postoperative Day 14 assessment, both returned for Day 30 postop assessment', 'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were enrolled at 24 clinical sites in the United States, beginning July 2009 and completing in October 2010', 'preAssignmentDetails': '176 participants were enrolled. 32 were screen failures. 1 was withdrawn by investigator (study coordinator not available to collect data), 2 participants requested withdrawal, 1 participant died prior to screening and prior to receiving study treatment. Therefore, 140 of the 176 enrolled were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FS VH S/D 500 S-apr', 'description': 'FS VH S/D 500 s-apr will be applied to the study suture line.'}, {'id': 'BG001', 'title': 'Control - Manual Compression With Surgical Gauze Pads', 'description': 'Dry gauze pads will be positioned to cover the complete study suture line.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '12.6', 'groupId': 'BG000'}, {'value': '66.3', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '12.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '140', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'dispFirstSubmitDate': '2011-12-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2009-05-04', 'dispFirstSubmitQcDate': '2011-12-02', 'resultsFirstSubmitDate': '2012-09-13', 'studyFirstSubmitQcDate': '2009-05-04', 'dispFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-10-26', 'studyFirstPostDateStruct': {'date': '2009-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.', 'timeFrame': '4 minutes post start of treatment application', 'description': 'Hemostasis at the study suture line must be maintained until closure of the surgical wound.'}, {'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\nModerate 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.'}, {'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 Who Achieved Hemostasis at 6 Minutes Post Treatment Application', 'timeFrame': '6 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 Who Achieved Hemostasis at 10 Minutes Post Treatment Application', '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 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', 'timeFrame': 'Postoperative through day 30 ± 5', 'description': 'Any rebleeding requiring surgical re-exploration'}, {'measure': 'Percentage of Participants With Graft Occlusion', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30', 'description': 'Determined clinically and defined as absence of blood flow through the graft.'}, {'measure': 'Percentage of Participants With Infection at the Surgical Site', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30'}, {'measure': 'Number of Participants With Infections by Grade', 'timeFrame': 'post-op discharge/day 1, post-op day 14 and day 30', 'description': 'Infections were recorded according to:\n\n* Grade I: only dermis affected\n* Grade II: infection invades subcutaneous region but not the arterial implant\n* Grade III: the arterial implant is infected'}, {'measure': 'Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline', 'timeFrame': 'Within 14 days prior to date of surgery'}, {'measure': 'Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure', 'timeFrame': 'Within 14 days prior to surgery 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': 'Within 14 days prior to surgery 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': 'Within 14 days prior to surgery through postoperative day 14', 'description': 'Percent Change in Heart Rate Measured as: 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': {'keywords': ['Vascular Surgery', 'Arterio-arterial bypasses', 'Arterio-venous (AV) shunts'], 'conditions': ['Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses']}, 'referencesModule': {'references': [{'pmid': '22633423', 'type': 'BACKGROUND', 'citation': 'Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPreoperative inclusion criteria:\n\n* Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:\n\n * axillo-femoral\n * axillo-bifemoral\n * aorto-bifemoral\n * ilio-femoral\n * femoro-femoral\n * ilio-popliteal\n * femoro-popliteal (including below knee)\n * femoro-tibial vessel bypass\n * arterio-venous shunting for dialysis access in the upper or lower extremity\n* Signed informed consent\n* Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.\n* Subject is willing and able to comply with the requirements of the protocol.\n\nIntraoperative inclusion criterion:\n\n* Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)\n\nExclusion Criteria:\n\nPreoperative exclusion criteria:\n\n* Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)\n* Congenital coagulation disorders\n* Prior kidney transplantation\n* Heparin-induced thrombocytopenia\n* Known hypersensitivity to heparin\n* Known hypersensitivity to aprotinin or other components of the product\n* Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)\n* Prior radiation therapy to the operating field\n* Severe local inflammation at the operating field\n* Subject is pregnant or lactating at the time of enrollment\n* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study\n* Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.\n\nIntraoperative Exclusion Criteria:\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, (eg, abandonment of ePTFE graft placement)'}, 'identificationModule': {'nctId': 'NCT00892957', 'briefTitle': 'FS VH S/D 500 S-apr in Vascular Surgery', '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': '550801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FS VH S/D 500 s-apr', 'description': 'FS VH S/D 500 s-apr will be applied to the study suture line.', 'interventionNames': ['Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Manual compression with surgical gauze pads', 'description': 'Dry gauze pads will be positioned to cover the complete study suture line.', 'interventionNames': ['Other: Surgical gauze pads']}], 'interventions': [{'name': 'Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)', 'type': 'BIOLOGICAL', 'otherNames': ['Biological two-component fibrin sealant'], 'description': 'The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).', 'armGroupLabels': ['FS VH S/D 500 s-apr']}, {'name': 'Surgical gauze pads', 'type': 'OTHER', 'description': 'Manual compression with surgical gauze pads', 'armGroupLabels': ['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': 'Fresno', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Orange', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'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': 'Saginaw', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 43.41947, 'lon': -83.95081}}, {'city': 'Southfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.47337, 'lon': -83.22187}}, {'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'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': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Isabella Presch, MD, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Innovations GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}