Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 2:07 AM
Study NCT ID:
NCT05047133
Status:
RECRUITING
Last Update Posted:
2021-09-16
First Post:
2021-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Early Administration of TXA in Adult Hip Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-08-09', 'mcpReleaseN': 1, 'releaseDate': '2023-07-19'}], 'estimatedResultsFirstSubmitDate': '2023-07-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019106', 'term': 'Postoperative Hemorrhage'}], 'ancestors': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Blood Transfusion', 'timeFrame': 'Up to two weeks', 'description': 'Patient receives a blood transfusion during their postoperative stay in the hospital'}, {'measure': 'Overall Blood Loss', 'timeFrame': 'Up to two weeks', 'description': 'Calculate the difference in postoperative blood loss between groups'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'Up to two weeks', 'description': 'Overall length of hospital stay'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Up to two weeks', 'description': 'Difference in overall pain scores between groups'}, {'measure': 'Wound complications', 'timeFrame': 'Up to two weeks', 'description': 'Acute wound complications documented after surgical intervention'}, {'measure': 'Acute DVT/PE', 'timeFrame': 'Up to two weeks', 'description': 'Documented deep venous thrombosis or pulmonary embolism'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Blood Loss']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study designed to assess blood loss in intracapsular and extracapsular hip fractures undergoing operative fixation at a Level II trauma center. It is well established in the orthopedic literature that tranexamic acid (TXA) decreases blood loss and need for postoperative blood transfusion in hip fracture patients as well as total joint arthroplasty patients. A typical dosing pattern, and the dosing pattern employed at our institution, is 1 gram IV infused prior to incision followed by 1 gram IV infused at the time of wound closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. All adult (18 years old or older) hip fracture patients presenting with an acute hip fracture and undergoing operative fixation\n\nExclusion Criteria:\n\n1. Polytrauma patients\n2. Previous operation on the ipsilateral hip\n3. Patients with coagulopathies (Factor V Leiden, Sickle Cell Anemia, Etc.)\n4. Patients with \\< 6-month history of thromboembolic event (DVT/PE), Stroke, Cardiac Stents, or Myocardial Infarction (MI)\n5. History of seizure disorder\n6. Patients on birth control\n7. Pregnant Women\n8. Prisoners\n9. Active thromboembolic disease (DVT/PE, MI, Stroke)'}, 'identificationModule': {'nctId': 'NCT05047133', 'briefTitle': 'Effect of Early Administration of TXA in Adult Hip Fractures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ascension Health'}, 'officialTitle': 'Does Early Administration of Tranexamic Acid Decrease Perioperative Blood Loss in Addition to Intraoperative Tranexamic Acid for Hip Fracture Patients?', 'orgStudyIdInfo': {'id': '1722787-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Adminstration of TXA + Intraoperative TXA', 'description': 'This group receives 1 G of TXA as soon as possible after a diagnosis of an acute hip fracture if the patient meets inclusion and exclusion criteria. The group will also receive 2 grams of TXA total intraoperatively.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'OTHER', 'label': 'Intraoperative only TXA', 'description': 'This group will only receive the intraoperative TXA.', 'interventionNames': ['Drug: Tranexamic acid']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Lysteda'], 'description': 'TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups', 'armGroupLabels': ['Early Adminstration of TXA + Intraoperative TXA', 'Intraoperative only TXA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48439', 'city': 'Grand Blanc', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sandra Watt, MS, BSN', 'role': 'CONTACT', 'email': 'sandra.watt@ascension.org', 'phone': '810-606-7713'}], 'facility': 'Ascension Genesys Hospital', 'geoPoint': {'lat': 42.92753, 'lon': -83.62995}}], 'centralContacts': [{'name': 'Jacob Hinkley, DO, MS', 'role': 'CONTACT', 'email': 'jacob.hinkley2@ascension.org', 'phone': '810-606-5669'}, {'name': 'Jacob Lytle, DO', 'role': 'CONTACT', 'email': 'jacob.lytle@ascension.org', 'phone': '810-606-5669'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascension Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Jacob Hinkley', 'investigatorAffiliation': 'Ascension Health'}}}}