Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid (TXA)

January 30, 2018 updated by: Brett Crist, University of Missouri-Columbia

Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study

This study is investigating the use of tranexamic acid (TXA) in patients with pelvis and/or hip socket fractures that require surgery. TXA is FDA-approved in patients with hemophilia for short-term use to reduce hemorrhage and the need for replacement blood during tooth extraction. However, it has also been used extensively in severely injured patients after major trauma and during elective hip and knee replacements. Previous studies indicate TXA may reduce blood loss and the need for blood transfusions while being safe for use in most patients. TXA is fairly inexpensive and easy to obtain.

The purpose of this study is to determine if TXA will make surgery in patients with pelvis and/or hip socket fractures safer and more cost efficient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study candidates will be identified as they present to the University Hospital emergency room and will be recruited for enrollment. Randomization will occur by electronic randomization software. Prior to surgery, the pharmacy will be notified of an enrolled patient and will be responsible for randomization and creating either a placebo intravenous dose or a treatment study dose. Both study groups will receive the standard of care treatment for intra-operative hemorrhage control.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (18 years of age or greater) with acetabulum fractures and/or pelvic ring injuries that require operative fixation via an open surgical approach

Exclusion Criteria:

  • Revision surgery
  • Surgery occurring more than 2 weeks post-injury
  • History of blood dyscrasia or renal insufficiency
  • History of any thromboembolic disease
  • Pregnancy or nursing, color vision defects
  • History of retinal detachment/degeneration
  • Intracranial hemorrhage
  • Hypersensitivity to tranexamic acid
  • Contraceptive Use (estrogens/progestins)
  • FEIBA (anti-inhibitor coagulant complex) use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Tranexamic Acid
Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Drug: Tranexamic Acid
10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
Other Names:
  • Transamin
  • Cyklokapron
PLACEBO_COMPARATOR: Placebo
The control group will receive a similar volume load of normal saline and maintenance doses.
Drug: Placebo
The control group will receive a similar volume load of normal saline and maintenance doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intra-operative Blood Loss
Time Frame: Day of Surgery
Day of Surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants That Required an Allogenic Transfusion
Time Frame: Perioperative (hospitalized period)
Perioperative (hospitalized period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (ESTIMATE)

January 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 27, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1208444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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