Overview

This trial is active, not recruiting.

Condition acetabulum fractures
Treatments tranexamic acid, placebo
Sponsor University of Missouri-Columbia
Start date August 2013
End date March 2016
Trial size 33 participants
Trial identifier NCT02051686, 1208444

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose treatment
Arm
(Active Comparator)
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.
tranexamic acid Cyklokapron
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 Comparator)
The control group will receive a similar volume load of normal saline and maintenance doses.
placebo
The control group will receive a similar volume load of normal saline and maintenance doses.

Primary Outcomes

Measure
Intra-operative blood loss
time frame: Day of Surgery

Secondary Outcomes

Measure
Total Blood Loss
time frame: At 2 and 6 weeks, and 3,6,9, and 12 months post-surgery

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid: A Prospective, Randomized, Controlled Study
Principal investigator Brett D Crist, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Missouri-Columbia.