Blood Loss After Early TXA in Hip Fractures.
Status unconfirmed · Early Phase 1 · Has a placebo group
Conditions studied: Hip Fractures
In brief
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.
Key facts
- Study ID
- NCT04488367
- Run by
- Community Memorial Health System
- People needed
- 120
- Starts
- 2020-07-06
- Expected to finish
- 2023-07-01
- Last updated by the study team
- 2022-07-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Femoral neck, intertrochanteric, subtrochanteric femur fracture
- Age >18
- Undergoing surgical stabilization or arthroplasty by any method as determined by attending surgeon
You may not qualify if…
- 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)
Where it is running
- Community Memorial Hospital — Ventura, California, United States (enrolling)
Full record on ClinicalTrials.gov
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