Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-03-12 @ 1:49 AM
Study NCT ID:
NCT03085394
Status:
TERMINATED
Last Update Posted:
2023-04-19
First Post:
2017-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'whyStopped': 'Enrollment stopped, patients refuse to participate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2017-03-19', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment efficiency (lowering/preventing clinically significant bleeding)', 'timeFrame': '1 week', 'description': 'The efficiency of preoperative tranexamic acid administration in lowering/preventing clinically significant bleeding.'}, {'measure': 'Treatment safety (administering tranexamic acid preoperatively without promoting thromboembolic events)', 'timeFrame': '2 months', 'description': 'The safety of administering tranexamic acid preoperatively without promoting thromboembolic events'}], 'secondaryOutcomes': [{'measure': 'Need for reintervention', 'timeFrame': '1 week', 'description': 'The proportion of patients requiring invasive intervention (percutaneous/operative) due to bleeding'}, {'measure': 'Procedure change', 'timeFrame': '1 day', 'description': 'The proportion of patients requiring alteration of intended procedure due to bleeding.'}, {'measure': 'Blood/blood product requirement', 'timeFrame': '1 week', 'description': 'The usage of blood/blood products after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Morbid Obesity', 'Sleeve gastrectomy'], 'conditions': ['Intra-Operative Injury - Other', 'Post Operative Hemorrhage', 'Tranexamic Acid']}, 'descriptionModule': {'briefSummary': 'Prophylactic use of tranexamic acid to reduce intra and postoperative bleeding in primary sleeve gastrectomy procedures will be studied.', 'detailedDescription': 'Patients scheduled for primary laparoscopic sleeve gastrectomy for the treatment of morbid obesity will be assigned to receive tranexamic acid vs. placebo before surgery. Intraoperative bleeding will be scored, as well as postoperative bleeding and blood or blood-product requirements. POstoperative venous thromboembolic events will be recorded up to 2 months following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Morbid obesity\n* Approved and scheduled for laparoscopic sleeve gastrectomy\n\nExclusion Criteria:\n\n* Previous bariatric surgery\n* Platelet count under 100,000\n* Concurrent anticoagulation treatment\n* Previous venous/atrerial thromboembolic event\n* Known allergy to tranexamic acid\n* History of heparin induced thrombocytopenia\n* Oral contraceptive use\n* Female hormonal replacement therapy\n* Active thromboembolic state\n* Genetic hypercoagulable state'}, 'identificationModule': {'nctId': 'NCT03085394', 'acronym': 'PHORBBS', 'briefTitle': 'Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Preoperative Hexakapron Reduces Bleeding in Bariatric Surgery', 'orgStudyIdInfo': {'id': 'SMC-17-3846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment arm', 'description': 'Preoperative intravenous administration of 2g tranexamic acid in 10ml fluid.', 'interventionNames': ['Drug: tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'Preoperative intravenous administration of 10ml normal saline.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'tranexamic acid', 'type': 'DRUG', 'otherNames': ['Hexakapron'], 'description': 'Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline', 'armGroupLabels': ['Treatment arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Preoperative intravenous administration of 10 ml saline', 'armGroupLabels': ['Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Bariatric and Metabolic Surgery', 'investigatorFullName': 'David Goitein MD', 'investigatorAffiliation': 'Sheba Medical Center'}}}}