Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT03654560
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2018-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'G.Abate@unitedhealthproductsinc.com', 'phone': '(386) 627-1598', 'title': 'Gerard Abate, MD Chief Medical Officer', 'organization': 'United Health Products, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From treatment to 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 3, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 4, 'seriousNumAtRisk': 118, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'notes': 'Abdominal pain that resolved. Not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pelvic Pain', 'notes': 'Pelvic Pain resolved, not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Bleeding Anterior Venous Fistula', 'notes': 'Bleeding of anterior venous fistula, not in the area of the treatment and not related to the study device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Seroma', 'notes': 'Seroma not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Constipation', 'notes': 'Constipation not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Pneumonia', 'notes': 'Patient had pneumonia requiring hospitalization, not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Soft Tissue infection', 'notes': 'Necrotizing soft tissue infection at site of surgery, requiring abdominal wall debridement. Not related to the study treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'OG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '47'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '10 minutes', 'description': 'The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.', 'unitOfMeasure': 'seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'OG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'classes': [{'title': '2 minutes', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': '5 minutes', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': '10 minutes', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between 2 minutes and 10 minutes', 'description': 'Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'OG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'classes': [{'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative period', 'description': 'Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'OG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intraoperative period post hemostasis', 'description': 'Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '6 subjects in the Surgicel cohort could not be analyzed because hemostasis was never obtained at the target bleeding site.'}, {'type': 'SECONDARY', 'title': 'Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'OG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', 'description': 'Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '3 subjects in the HemoStyp cohort and 6 subjects in the Surgicel cohort did not finish the 30 day follow up so they were not included in the analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'FG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '118'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '117'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.\n\nHemoStyp: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.'}, {'id': 'BG001', 'title': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.\n\nSurgicel: During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.89', 'spread': '16.13', 'groupId': 'BG000'}, {'value': '61.48', 'spread': '16.48', 'groupId': 'BG001'}, {'value': '60.19', 'spread': '16.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '139', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '179', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.84', 'spread': '19.59', 'groupId': 'BG000'}, {'value': '168.55', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '166.69', 'spread': '19.59', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.94', 'spread': '38.62', 'groupId': 'BG000'}, {'value': '86.48', 'spread': '49.88', 'groupId': 'BG001'}, {'value': '83.24', 'spread': '38.62', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '124.11', 'spread': '25.14', 'groupId': 'BG000'}, {'value': '124.53', 'spread': '26.75', 'groupId': 'BG001'}, {'value': '124.26', 'spread': '26.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '67.34', 'spread': '16.87', 'groupId': 'BG000'}, {'value': '67.48', 'spread': '16.09', 'groupId': 'BG001'}, {'value': '67.45', 'spread': '16.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart Rate', 'classes': [{'categories': [{'measurements': [{'value': '71.26', 'spread': '13.87', 'groupId': 'BG000'}, {'value': '71.89', 'spread': '13.12', 'groupId': 'BG001'}, {'value': '71.54', 'spread': '13.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats Per minute', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '12.37', 'spread': '2.83', 'groupId': 'BG000'}, {'value': '12.14', 'spread': '2.69', 'groupId': 'BG001'}, {'value': '12.25', 'spread': '2.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'grams per deciliter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '40.18', 'spread': '26.52', 'groupId': 'BG000'}, {'value': '36.16', 'spread': '7.71', 'groupId': 'BG001'}, {'value': '38.15', 'spread': '26.52', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Platelet Count', 'classes': [{'categories': [{'measurements': [{'value': '212.83', 'spread': '92.5', 'groupId': 'BG000'}, {'value': '221.81', 'spread': '99.45', 'groupId': 'BG001'}, {'value': '217.36', 'spread': '92.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'platelets per micro liter of blood', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Type of Surgery', 'classes': [{'categories': [{'title': 'Abdominal Surgery', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Thoracic Surgery', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Vascular Surgery', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Lewis Bleeding Scale Grade', 'classes': [{'categories': [{'title': 'Lewis Bleeding Scale Grade 1', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Lewis Bleeding Scale Grade 2', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Investigator rated the intensity of the bleeding at the target bleeding site (TBS) according to the validated bleeding scale (Lewis 2017) shown below.\n\nLewis Bleeding Scale Description:\n\nGrade 1 is an ooze or intermittent flow with capillary-like bleeding, described as mild bleeding with \\>1.0-5.0 milliliters per minutes (ML/Min) blood loss.\n\nGrade 2 is a continuous flow, venule and arteriolar-like bleeding described as moderate bleeding with \\>5.0-10.0 ML/Min blood loss', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-02', 'size': 801982, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-01T00:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-27', 'studyFirstSubmitDate': '2018-08-27', 'resultsFirstSubmitDate': '2020-09-02', 'studyFirstSubmitQcDate': '2018-08-28', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-27', 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Time to Hemostasis Measured From Start of Study Treatment to the Achievement of Hemostasis at the Target Bleeding Site (TBS), or to the End of the 10-minute Observation Period.', 'timeFrame': '10 minutes', 'description': 'The time to hemostasis was measured from start of study treatment to the achievement of hemostasis at the target bleeding site (TBS), or to the end of the 10-minute observation period. The time to hemostasis was considered as censored at the end of the 10-minute observation period. Time to hemostasis was quantified in minutes according to its nominal time point. When re-bleeding occurred, and the cessation of bleeding is again achieved at a later time point, the effective time to hemostasis was the latter time point. The time to hemostasis was the time from start of study treatment to that last effective hemostatic time point.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Hemostasis Between 2 Minutes and 10 Minutes', 'timeFrame': 'Between 2 minutes and 10 minutes', 'description': 'Percentage of subjects achieving hemostasis at the target bleeding site at 2 minutes, 5 minutes and 10 minutes following the start of study treatment.'}, {'measure': 'Rate of Subjects Achieving Intraoperative Hemostasis at the Target Bleeding Site', 'timeFrame': 'Intraoperative period', 'description': 'Percentage of subjects with intraoperative hemostasis at the target bleeding site during the intraoperative period. The intraoperative period started when the first cut was made to the patient and ended when the operative field was closed and dressed.'}, {'measure': 'Rate of Subjects With Intraoperative Re-bleeding From the Target Bleeding Site', 'timeFrame': 'Intraoperative period post hemostasis', 'description': 'Percentage of subjects with intraoperative re-bleeding from the target bleeding site post hemostasis'}, {'measure': 'Rate of Subjects Requiring Surgical Re-exploration up to 30 Days After Surgery for Re-bleeding From the Target Bleeding Site', 'timeFrame': '30 days', 'description': 'Postoperative re-bleeding from the target bleeding site requiring surgical re exploration up to 30 days after surgery.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemostasis', 'Bleeding']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess efficacy and safety of HemoStyp as an adjunct for management of secondary hemostasis in the operative setting.', 'detailedDescription': 'This study is a prospective, non-inferiority, multi-center, randomized, open-label trial to compare HemoStyp with Surgicel® in the management of bleeding during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery);\n2. At time of surgery has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical;\n3. Ages: Pediatric subjects 2 years to 17 years of age and adult subjects 18 years of age or older; and\n4. Subjects or parent or legal guardian of the subject who are willing and able to sign consent.\n\nExclusion Criteria:\n\n1. Physical or psychological condition which would impair study participation;\n2. Indications for emergency surgery;\n3. Pre-operative laboratory findings of a hematologic disorder;\n4. Subjects with history of moderate to severe allergies;\n5. Subjects undergoing minimally invasive laparoscopic surgery;\n6. Subjects who will require platelet or fresh frozen plasma transfusion during surgery;\n7. Subjects who are pregnant or breast-feeding at the time of surgery; or\n8. Subjects on P2Y12 platelet inhibitor (Plavix) less than 5 days prior to surgery, warfarin or Xa inhibitors not withheld per standard protocols for the management of anticoagulants pre-operatively.'}, 'identificationModule': {'nctId': 'NCT03654560', 'briefTitle': 'Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Health Products, Inc.'}, 'officialTitle': 'Efficacy and Safety of HemoStyp as an Adjunct for Management of Secondary Hemostasis in the Operative Setting', 'orgStudyIdInfo': {'id': 'UHP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'HemoStyp', 'description': 'Subjects with an appropriate target bleeding site will have Hemostyp applied in accordance to instructions for use.', 'interventionNames': ['Device: HemoStyp']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgicel', 'description': 'Subjects with an appropriate target bleeding site will have Surgicel applied in accordance to instructions for use.', 'interventionNames': ['Device: Surgicel']}], 'interventions': [{'name': 'HemoStyp', 'type': 'DEVICE', 'description': 'During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.', 'armGroupLabels': ['HemoStyp']}, {'name': 'Surgicel', 'type': 'DEVICE', 'description': 'During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.', 'armGroupLabels': ['Surgicel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Raymond Schaerf', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Health Products, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}