Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-03 @ 10:24 PM
Study NCT ID:
NCT02780869
Status:
COMPLETED
Last Update Posted:
2018-12-27
First Post:
2016-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HEMOBLAST Pivotal Clinical Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005781', 'term': 'Gelatin Sponge, Absorbable'}], 'ancestors': [{'id': 'D015503', 'term': 'Surgical Sponges'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'r.hoffman@biomup.com', 'phone': '404-702-9253', 'title': 'Rachel Hoffman, Vice President Clinical Operations North America', 'organization': "Biom'up"}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Enrollment until completion of 6-week follow-up visit', 'description': "All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'", 'eventGroups': [{'id': 'EG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows', 'otherNumAtRisk': 175, 'deathsNumAtRisk': 175, 'otherNumAffected': 84, 'seriousNumAtRisk': 175, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin', 'otherNumAtRisk': 83, 'deathsNumAtRisk': 83, 'otherNumAffected': 47, 'seriousNumAtRisk': 83, 'deathsNumAffected': 3, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Abnormal bloodwork', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation/ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'notes': 'Non wound-related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wound related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Melena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'RA lead dislodgement', 'notes': 'RA lead dislodgement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin rash/hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dehisence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects Achieving Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows'}, {'id': 'OG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin'}], 'classes': [{'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Stratified adjustments for surgery type were made using the Cochran-Mantel-Haenszel weighting.', 'nonInferiorityComment': 'The primary endpoint was designed to establish comparable efficacy based upon a non-inferiority margin of 10% for the difference in the probability of TTH within 6 minutes comparing HEMOBLAST™ to G+T (HEMOBLAST™- G+T). Letting θ denote the true difference in the probability of hemostasis at 6 minutes between HEMOBLAST™ to G+T, the trial will test the null hypothesis H0: θ ≤ -0.10 vs. the alternative hypothesis HA : θ \\> -0.10 using a one-sided level 0.025 test.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05', 'groupDescription': 'A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative, 6 Minutes Post-Application', 'description': 'The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.'}, {'type': 'SECONDARY', 'title': 'Product Preparation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows'}, {'id': 'OG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.37', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '2.40', 'spread': '0.794', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjustment for mulitple comparisons were made when assessing secondary endpoints using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05', 'groupDescription': 'The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Achieving Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows'}, {'id': 'OG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin'}], 'classes': [{'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Adjustment for multiple comparisons when assessing secondary endpoints was performed using a fixed sequence closed testing procedure to control the family-wise type I error rate at 0.05.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The difference in the probability of hemostasis within 3 minutes was tested using a logistic regression model with stratified adjustment for surgery type.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative, 3 Minutes Post-Application', 'description': 'The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows\n\nHEMOBLAST Bellows'}, {'id': 'FG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin\n\nAbsorbable gelatin sponge, USP with thrombin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'First subject completed follow-up: August 19, 2016 Last patient completed follow-up: January 18, 2017', 'preAssignmentDetails': 'Subject enrollment occurred after the subject met preoperative eligibility criteria, gave written informed consent, and met intraoperative eligibility criteria. Subjects were randomized and treated subsequent to enrollment. Subjects could withdraw or be withdrawn from the study at any time after enrollment, including prior to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Investigational', 'description': 'HEMOBLAST Bellows'}, {'id': 'BG001', 'title': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '14.79', 'groupId': 'BG000'}, {'value': '56.2', 'spread': '14.62', 'groupId': 'BG001'}, {'value': '56.7', 'spread': '14.71', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '155', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-20', 'size': 865150, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-08T12:35', 'hasProtocol': True}, {'date': '2016-07-01', 'size': 1326061, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-08T12:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2016-05-19', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2018-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-08', 'studyFirstPostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects Achieving Hemostasis', 'timeFrame': 'Intraoperative, 6 Minutes Post-Application', 'description': 'The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.'}], 'secondaryOutcomes': [{'measure': 'Product Preparation Time', 'timeFrame': 'Intraoperative', 'description': 'The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.'}, {'measure': 'Proportion of Subjects Achieving Hemostasis', 'timeFrame': 'Intraoperative, 3 Minutes Post-Application', 'description': 'The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hemostasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery;\n\n * Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation;\n * Subject undergoing cardiothoracic surgery is not allergic to protamine; and\n * Subject is 21 years of age or older.\n\nExclusion Criteria:\n\n* • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure;\n\n * Subject is undergoing a neurologic surgical procedure;\n * Subject is undergoing a spinal surgical procedure;\n * Subject is undergoing an emergency surgical procedure;\n * Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;\n * Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \\< 100,000 per microliter or International Normalized Ratio \\> 1.5 within 4 weeks of surgery;\n * Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery;\n * Subject receiving antiplatelet medications within 5 days prior to surgery;\n * Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery;\n * Subject has an active or suspected infection at the surgical site;\n * Subject has had or has planned to receive any organ transplantation;\n * Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;\n * Subject has ASA classification of 5;\n * Subject has a life expectancy of less than 3 months;\n * Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study;\n * Subject has a documented severe congenital or acquired immunodeficiency;\n * Subject has religious or other objections to porcine, bovine, or human components;\n * Subject in whom the investigational or control device will be used at the site of a valve replacement or repair;\n * Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant;\n * Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and\n * Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator.\n\nIntraoperative Eligibility Criteria:\n\n* Subject does not have an active or suspected infection at the surgical site;\n* Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment;\n* Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and\n* Subject has a TBS with an SBSS score of 1, 2, or 3.'}, 'identificationModule': {'nctId': 'NCT02780869', 'briefTitle': 'HEMOBLAST Pivotal Clinical Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': "Biom'Up France SAS"}, 'officialTitle': 'Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries', 'orgStudyIdInfo': {'id': 'ETC 2015-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational', 'description': 'HEMOBLAST Bellows', 'interventionNames': ['Device: HEMOBLAST Bellows']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Absorbable gelatin sponge, USP with thrombin', 'interventionNames': ['Device: Absorbable gelatin sponge, USP with thrombin']}], 'interventions': [{'name': 'HEMOBLAST Bellows', 'type': 'DEVICE', 'armGroupLabels': ['Investigational']}, {'name': 'Absorbable gelatin sponge, USP with thrombin', 'type': 'DEVICE', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'CORE Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Lotus Clinical Research', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Plastic Surgery', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Queens Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Suburban Hospital - Johns Hopkins Medicine', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Hanover', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.70229, 'lon': -72.28954}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center / New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Huntsville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Hunstad Kortesis Center', 'geoPoint': {'lat': 36.08236, 'lon': -80.5295}}, {'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Liver Disease and Transplant Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Spectrum Medical', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}], 'overallOfficials': [{'name': 'William Chapman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Biom'Up France SAS", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}