Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT04488367
Status:
UNKNOWN
Last Update Posted:
2022-07-19
First Post:
2020-07-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Loss After Early TXA in Hip Fractures.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-18', 'studyFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in calculated and recorded hemoglobin', 'timeFrame': 'From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.', 'description': 'Change in hemoglobin (blood loss) will be assessed based on preoperative blood draw and blood draws post op and on each inpatient day during hospitalization.'}, {'measure': 'Total postoperative units of red blood cell transfusion', 'timeFrame': 'From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first.', 'description': 'The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.'}], 'secondaryOutcomes': [{'measure': 'VTE', 'timeFrame': 'Postoperative for 30 days', 'description': 'DVT or PE'}, {'measure': 'Infection', 'timeFrame': 'Postoperative for 30 days', 'description': 'Superficial and deep infections'}, {'measure': 'Readmission', 'timeFrame': 'Within 30 days postoperative', 'description': '30 day readmission'}, {'measure': 'Other complications', 'timeFrame': 'Postoperative for 30 days', 'description': 'Any additional unforeseen complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'TXA', 'hip fracture'], 'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '18349013', 'type': 'BACKGROUND', 'citation': 'Foss NB, Kristensen MT, Kehlet H. Anaemia impedes functional mobility after hip fracture surgery. Age Ageing. 2008 Mar;37(2):173-8. doi: 10.1093/ageing/afm161.'}, {'pmid': '27551568', 'type': 'BACKGROUND', 'citation': 'Praetorius K, Madsen CM, Abrahamsen B, Jorgensen HL, Lauritzen JB, Laulund AS. Low Levels of Hemoglobin at Admission Are Associated With Increased 30-Day Mortality in Patients With Hip Fracture. Geriatr Orthop Surg Rehabil. 2016 Sep;7(3):115-20. doi: 10.1177/2151458516647989. Epub 2016 May 17.'}, {'pmid': '20554319', 'type': 'BACKGROUND', 'citation': 'CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.'}, {'pmid': '28810918', 'type': 'BACKGROUND', 'citation': 'Lei J, Zhang B, Cong Y, Zhuang Y, Wei X, Fu Y, Wei W, Wang P, Wen S, Huang H, Wang H, Han S, Liu S, Zhang K. Tranexamic acid reduces hidden blood loss in the treatment of intertrochanteric fractures with PFNA: a single-center randomized controlled trial. J Orthop Surg Res. 2017 Aug 15;12(1):124. doi: 10.1186/s13018-017-0625-9.'}, {'pmid': '28031511', 'type': 'BACKGROUND', 'citation': 'Baruah RK, Borah PJ, Haque R. Use of tranexamic acid in dynamic hip screw plate fixation for trochanteric fractures. J Orthop Surg (Hong Kong). 2016 Dec;24(3):379-382. doi: 10.1177/1602400322.'}, {'pmid': '28983887', 'type': 'BACKGROUND', 'citation': 'Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.'}, {'pmid': '29426608', 'type': 'BACKGROUND', 'citation': 'Tian S, Shen Z, Liu Y, Zhang Y, Peng A. The effect of tranexamic acid on hidden bleeding in older intertrochanteric fracture patients treated with PFNA. Injury. 2018 Mar;49(3):680-684. doi: 10.1016/j.injury.2018.01.026. Epub 2018 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Our present study aims to initiate TXA administration immediately upon diagnosis of hip fracture in the Emergency Department. This will be a single blind randomized controlled trial comparing early administration of TXA in the ED in addition to perioperative dosing versus the standard perioperative administration only. The study population will include patients who have sustained a femoral neck, intertrochanteric, or subtrochanteric femur fracture and are undergoing surgical internal fixation or arthroplasty. We will prospectively compare the need for blood transfusion, total and hidden blood loss, postoperative complications, length of stay and readmission within 30 days.', 'detailedDescription': 'Consent will be obtained for study enrollment from the patient or legal decision maker. The patient will then be randomized and stratified based on the fracture type, fixation method anticipated, and presence of anticoagulation.\n\nTreatment drug and saline placebo will be blinded from the patient. Treatment arm patients will receive a dose of 10 mg/kg of TXA IV as soon as possible in the ED. They will then receive repeat doses prior to skin incision and again after the end of surgery. Control group will receive a placebo dose of normal saline in the ED and then the standard 10 mg/kg TXA doses prior to surgery and again after the end of surgery. The perioperative doses will not be blinded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Femoral neck, intertrochanteric, subtrochanteric femur fracture\n* Age \\>18\n* Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon\n\nExclusion Criteria:\n\n* Age \\<18\n* Concomitant fracture\n* Preoperative anemia needing blood transfusion before surgery\n* Severe comorbidity (active cancer, severe pulmonary disease, ESRD)\n* Allergy for tranexamic acid\n* History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months\n* Myocardial infarction in the previous 12 months\n* Renal function impairment (creatinine clearance \\<30 mL/min), or kidney transplant\n* History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)'}, 'identificationModule': {'nctId': 'NCT04488367', 'briefTitle': 'Blood Loss After Early TXA in Hip Fractures.', 'organization': {'class': 'OTHER', 'fullName': 'Community Memorial Health System'}, 'officialTitle': 'The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.', 'orgStudyIdInfo': {'id': 'TXARCT1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early TXA', 'description': 'Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.', 'interventionNames': ['Drug: Normal Saline']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Early TXA'], 'description': '10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU', 'armGroupLabels': ['Early TXA']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Control Placebo'], 'description': '100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93003', 'city': 'Ventura', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Allen', 'role': 'CONTACT', 'email': 'mallen@cmhshealth.org', 'phone': '805-948-5100'}], 'facility': 'Community Memorial Hospital', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'centralContacts': [{'name': 'Michael Allen, DO', 'role': 'CONTACT', 'email': 'mallen@cmhshealth.org', 'phone': '805-948-5100'}], 'overallOfficials': [{'name': 'Michael Allen, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident physician'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Community Memorial Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michael Allen', 'investigatorAffiliation': 'Community Memorial Health System'}}}}