drugset / Trial / NCT05518279

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

NCT05518279

Phase 3 Withdrawn Henry Ford Health System
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-09
Primary completion
2021-08
Completion
2021-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 1950 mg Oral

Indications