The Effect of Tranexamic Acid on Blood Loss and Transfusion Requirements Following Open Femur Fracture Surgery

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2021-04-01

Brief Summary

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The purpose of this study is to determine the effect of tranexamic acid (TXA) on blood loss and transfusion requirements in patients with femur fractures requiring open surgical approaches.

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Detailed Description

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Conditions

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Blood Loss Following Open Femur Fracture Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranexamic acid (TXA)

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Group Type EXPERIMENTAL

Tranexamic acid (TXA)

Intervention Type DRUG

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Normal saline

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Interventions

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Tranexamic acid (TXA)

Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.

Intervention Type DRUG

Normal saline

Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients admitted to Memorial Hermann Medical Center with acute femur fractures that require open surgical approaches for fracture reduction and implant application, including patients with subtrochanteric, high-energy intertrochanteric, periprosthetic, and intra-articular distal femur fractures.

Exclusion Criteria

* Preoperative use of any anticoagulant
* History of deep venous thrombosis or pulmonary embolus
* Allergy to TXA
* Hepatic dysfunction (AST/ALT \> 60)
* Renal dysfunction (Cr \> 1.5 or GFR \< 30)
* History of cerebrovascular accident in the past 12 months
* Active coronary artery disease (event in the past 12 months)
* Presence of drug-eluting stent
* Color blindness
* Presence of an additional acute injury that could contribute to blood transfusion requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No