Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid
This trial is active, not recruiting.
|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|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver)|
Intra-operative blood loss
time frame: Day of Surgery
Total Blood Loss
time frame: At 2 and 6 weeks, and 3,6,9, and 12 months post-surgery
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
|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.|
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