Blood Loss After Early TXA in Hip Fractures.
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|ClinicalTrials.gov Identifier: NCT04488367|
Recruitment Status : Recruiting
First Posted : July 28, 2020
Last Update Posted : July 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Hip Fractures||Drug: Tranexamic acid Drug: Normal Saline||Early Phase 1|
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.
Treatment 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of the Timing of Tranexamic Acid Administration on Blood Loss in Hip Fractures.|
|Actual Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Early TXA
Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.
Drug: Tranexamic acid
10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
Other Name: Early TXA
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.
Drug: Normal Saline
100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
Other Name: Control Placebo
- Change in calculated and recorded hemoglobin [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]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.
- Total postoperative units of red blood cell transfusion [ Time Frame: From the time of randomization until discharge from the hospital after initial admission, or 4 weeks, whichever came first. ]The number of units of RBC transfusions will be recorded and compared between treatment and placebo groups.
- VTE [ Time Frame: Postoperative for 30 days ]DVT or PE
- Infection [ Time Frame: Postoperative for 30 days ]Superficial and deep infections
- Readmission [ Time Frame: Within 30 days postoperative ]30 day readmission
- Other complications [ Time Frame: Postoperative for 30 days ]Any additional unforeseen complications
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Femoral neck, intertrochanteric, subtrochanteric femur fracture
- Age >18
- Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
- Age <18
- Concomitant fracture
- Preoperative anemia needing blood transfusion before surgery
- Severe comorbidity (active cancer, severe pulmonary disease, ESRD)
- Allergy for tranexamic acid
- History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke, TIA) in the previous 12 months
- Myocardial infarction in the previous 12 months
- Renal function impairment (creatinine clearance <30 mL/min), or kidney transplant
- History of hypercoagulability (Factor V Leiden, Protein C/S deficiency)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488367
|Contact: Michael Allen, DOfirstname.lastname@example.org|
|United States, California|
|Community Memorial Hospital||Recruiting|
|Ventura, California, United States, 93003|
|Contact: Michael Allen 805-948-5100 email@example.com|
|Principal Investigator:||Michael Allen, DO||Resident physician|
|Responsible Party:||Michael Allen, Principal Investigator, Community Memorial Health System|
|Other Study ID Numbers:||
|First Posted:||July 28, 2020 Key Record Dates|
|Last Update Posted:||July 19, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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