Tranexamic Acid in Orthopaedic Trauma Surgery

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Tranexamic acid is an antifibrinolytic drug that has been used to decrease post-operative blood loss. This study is a prospective, randomized controlled trial investigating the use of tranexamic acid in fracture surgery around the hip and knee, in which significant blood loss (>300mL) is expected.

The hypothesis of this study is that tranexamic acid will be associated with a decrease in post-operative blood loss, as well as a decreased need for allogenic blood transfusion, in patients who have fracture surgery around the hip and knee.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Tennessee
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Patients with isolated fractures of the pelvic ring, acetabulum, femur or tibia that will require open reduction and internal fixation

• Expected blood loss is greater than 300 mL

• Age ≥ 18

• Skeletal maturity

Exclusion Criteria:

• Pregnant or breastfeeding

• Patients taking oral contraceptives

• Contraindication to venous thromboembolic event (VTE) prophylaxis (intracranial, intrathoracic, intra-abdominal bleeding or spine fractures)

• Patients requiring operative intervention for other injuries (orthopaedic or non-orthopaedic)

• Known hypercoagulable state including history of prescribed anti-coagulation (warfarin, plavix, low molecular weight heparin)

• Renal Insufficiency (creatinine greater than 1.5mg/dL)

• Open fractures