drugset / Trial / NCT00824564

Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

NCT00824564 ↗

Phase 4 Completed 82 enrolled Pfizer
RandomizedParallel-groupOpen-labelPrevention

Summary

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.

Timeline

Start
2009-04
Primary completion
2010-06
Completion
2010-06

Outcome

Missed primary endpoint

registry Tranexamic Acid Plus Standard of Care vs Standard of Care; p = 0.348; Mean Difference (Final Values) -55.5 (95% CI -172.7 to 61.7) NCT00824564 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 15 mg/kg Intravenous

Indications

No indication recorded.