Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid

Not Applicable

Completed

• Conditions: Acetabulum Fractures
• Interventions: Drug: Tranexamic Acid; Drug: Placebo

• Registration Number: NCT02051686
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-01-31
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2017-11-14
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-04
• Results First Posted: 2018-01-30
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid	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.
Placebo	Placebo	The control group will receive a similar volume load of normal saline and maintenance doses.

Primary Outcome Measures

Name	Time	Method
Intra-operative Blood Loss	Day of Surgery

Secondary Outcome Measures

Name	Time	Method
Number of Participants That Required an Allogenic Transfusion	Perioperative (hospitalized period)

Trial Locations

Locations (1)

University of Missouri; 🇺🇸 Columbia, Missouri, United States