N/A
N=88
Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
Acetabulum Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02051686 ↗Enrolled (actual)
88
Serious AEs
1.1%
Results posted
Jan 2018
Primary outcome: Primary: Intra-operative Blood Loss — 727.6; 560.1 Milliliters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tranexamic Acid (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-operative Blood Loss |
727.6; 560.1 | — |
| SECONDARY Number of Participants That Required an Allogenic Transfusion |
21; 15 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02051686). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.