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OpenTrials
Completed

NCT Number: NCT02051686

Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

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.

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Key information

Conditions

Acetabulum Fractures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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: Cyklokapron, Transamin

Placebo

Drug

The control group will receive a similar volume load of normal saline and maintenance doses.

Primary outcomes

  1. Intra-operative Blood Loss

    Time frame: Day of Surgery

Secondary outcomes

  1. Number of Participants That Required an Allogenic Transfusion

    Time frame: Perioperative (hospitalized period)

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

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

Acronym: TXA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 31, 2014
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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