Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-25 @ 5:21 PM
Study NCT ID:
NCT01326403
Status:
UNKNOWN
Last Update Posted:
2012-06-07
First Post:
2011-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in Hip Fracture Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-06-06', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-29', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of blood loss per patient from admission to day 5 post-op', 'timeFrame': '5 DAYS'}], 'secondaryOutcomes': [{'measure': 'Number of packed cell transfusion per patient.', 'timeFrame': '5 DAYS'}, {'measure': 'Initial functional outcome and feeling of well-being.', 'timeFrame': '5 days'}, {'measure': 'thromboembolic events', 'timeFrame': '5 days'}, {'measure': 'post-operative bacterial infection', 'timeFrame': '5 days'}, {'measure': '30 day mortality rate', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['proximal', 'hip', 'fractures'], 'conditions': ['Closed Fracture of Hip']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.', 'detailedDescription': "1. transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection\n2. Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding.\n3. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty.\n4. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state.\n5. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).\n* Patients mentally capable of giving informed consent.\n\nExclusion Criteria:\n\n1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.\n2. Patients receiving anticoagulation therapy with Coumadin or Plavix.\n3. Pregnancy and breastfeeding females.\n4. Previous arterial or venous thrombosis\n5. History of seizures.\n6. Creatinine \\>2.\n7. Oestroprogestive therapy.\n8. Multiple fractures.'}, 'identificationModule': {'nctId': 'NCT01326403', 'briefTitle': 'Tranexamic Acid in Hip Fracture Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Tranexamic Acid in Hip Fracture Patients', 'orgStudyIdInfo': {'id': 'TASMC-11-ES-0129-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Patients will receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'GROUP B', 'description': 'Patients will receive IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'GROUP C', 'description': 'A control group will only receive placebo in the emergency room and in the OR.', 'interventionNames': ['Drug: Tranexamic acid']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['placebo group', 'post injury group', 'preoperative group'], 'description': 'GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.\n\nGROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.\n\nGroup C - A control group will only receive placebo in the emergency room and in the OR.', 'armGroupLabels': ['GROUP B', 'GROUP C', 'Group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'contacts': [{'name': 'ELI STEINBERG, MD', 'role': 'CONTACT', 'email': 'STEINBERGE@TASMC.HEALTH.GOV.IL', 'phone': '0524266346'}, {'name': 'AMIR SHLAIFER, MD', 'role': 'CONTACT', 'email': 'SHLAIFER.MD@GMAIL.COM', 'phone': '0527360803'}], 'facility': 'Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'ELI SHTEINBERG, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michal Roll PhD,MBA', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'division of research and development TASMC', 'investigatorFullName': 'Michal Roll PhD,MBA', 'investigatorAffiliation': 'Tel-Aviv Sourasky Medical Center'}}}}