Tranexamic Acid in Orthopaedic Trauma Surgery

University of Tennessee

Status

Unknown

Conditions

Fracture

Surgery

Trauma

Blood Loss

Treatments

Drug: Tranexamic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02080494

11-036

Details and patient eligibility

About

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.

Enrollment

101 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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