Tranexamic Acid in Orthopaedic Trauma Surgery

Not Applicable

• Conditions: Blood Loss; Trauma; Fracture; Surgery
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT02080494
• Lead Sponsor: University of Tennessee

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-07-09
• Last Update Posted: 2018-07-11
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	Tranexamic Acid	15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose

Primary Outcome Measures

Name	Time	Method
hemoglobin value	through postoperative day four

Secondary Outcome Measures

Name	Time	Method
hematocrit value	through postoperative day four
number of units of allogenic blood transfused	through postoperative day four

Trial Locations

Locations (1)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States