Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures

• Status: Withdrawn
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Age over 50

• Clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture

Exclusion Criteria:

• anticoagulant use at time of admission to emergency department

• documented allergy to tranexamic acid

• history of deep vein thrombosis or pulmonary embolism

• hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 60)

• renal dysfunction (Creatinine > 1.5 or Glomerular Filtration Rate < 30)

• active coronary artery disease (event within 12 months)

• history of cerebral vascular accident within 12 months

• presence of drug eluting stent

• color blindness

• active cancer

• coagulopathy (International Normalized Ratio > 1.4, Partial Thromboplastin Time > 1.4 times normal, platelets < 50,000)