Tranexamic Acid in Orthopaedic Trauma Surgery

N/AUnknownNCT02080494

University of Tennessee101 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

101

Conditions

Blood Loss Trauma Fracture Surgery

Interventions

Tranexamic AcidDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Erlanger Health System

Chattanooga, Tennessee, United States

Outcomes

Primary Outcomes

hemoglobin value

Time frame: through postoperative day four

Secondary Outcomes

hematocrit value

Time frame: through postoperative day four

number of units of allogenic blood transfused

Time frame: through postoperative day four

Data from ClinicalTrials.gov

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