Tranexamic Acid in Orthopaedic Trauma Surgery

NCT ID: NCT02080494

Last Updated: 2018-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Blood Loss Trauma Fracture Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

No tranexamic acid given

Group Type NO_INTERVENTION

No interventions assigned to this group

Tranexamic Acid

15 mg/kg preoperative IV dose followed by another 15 mg/kg IV dose three hours after the initial dose

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

Interventions

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Tranexamic Acid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dirk W Kiner, MD

Role: PRINCIPAL_INVESTIGATOR

UTCOM Chattanooga / Erlanger Health System

Locations

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Erlanger Health System

Chattanooga, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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11-036

Identifier Type: -

Identifier Source: org_study_id

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