Tranexamic Acid in Intertrochanteric and Subtrochanteric Femur Fractures
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Hip Fractures, Surgical Blood Loss
In brief
The objective of this study is to evaluate the effect of Tranexamic Acid (TXA) on blood loss and need for perioperative blood transfusion following intertrochanteric and subtrochanteric femur fractures. TXA is a antifibrinolytic medication that prevents the breakdown of blood clots by inhibiting the activation of plasminogen to plasmin in the coagulation cascade. Our hypothesis is that by providing TXA at the time of hospital admission it will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for post-operative transfusion. This a double blinded, placebo controlled, therapeutic trial in which half of patients will be randomized to receive TXA at the time of hospital admission and half of patients will receive a placebo.
Key facts
- Study ID
- NCT02580227
- Run by
- Good Samaritan Regional Medical Center, Oregon
- People needed
- 100
- Starts
- 2015-06-01
- Expected to finish
- 2017-03-01
- Last updated by the study team
- 2015-10-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients sustaining a closed intertrochanteric femur fracture presenting to the Good Samaritan Regional Medical Center.
- Patients who are willing and able to consent to participate in the study
- >18 years of age
You may not qualify if…
- Patients with an allergy to tranexamic acid.
- History of thromboembolic event (pulmonary embolism, cerebral vascular accident, deep venous thrombosis),
- History of renal impairment (Cr > 1.5 or glomerular filtration rate < 30)
- Coronary stents
- History of hypercoagulability (Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant).
- Color blindness
- Subarachnoid hemorrhage
Where it is running
- Good Samaritan Hospital Corvallis — Corvallis, Oregon, United States (enrolling)
Full record on ClinicalTrials.gov
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