Status:
COMPLETED
Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Foundation for Orthopedic Trauma
Conditions:
Fracture of Posterior Wall of Acetabulum
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in ...
Detailed Description
In this prospective, randomized, double-blinded, multi-center study comparing topical TXA with placebo, investigators will determine whether topical TXA utilization in isolated PW acetabular surgery h...
Eligibility Criteria
Inclusion
- Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury. Upper extremity fractures that are non-operative and have no impact on weight-bearing status will be included.
- Patients must be skeletally mature.
Exclusion
- Patients are not skeletally mature.
- Patients with any concomitant lower extremity, pelvis, or spine injuries.
- Patient admitted as a polytrauma patient to the trauma service due to injury to an internal organ (head, chest, or abdomen).
- Patient has an unidentified source of hemorrhage other than acetabular fracture.
- Patient requires surgery for treatment of concomitant injuries.
- Patient requires multiple surgeries.
- Patient has pre-existing thrombus prior to surgery.
- Patient with a history of prior pulmonary embolus or other thromboembolic disease.
- Patient with a known bleeding disorder.
- Patient with a history of renal insufficiency.
- Patient who is unable to give consent or is unconscious.
Key Trial Info
Start Date :
August 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05357079
Start Date
August 25 2017
End Date
December 2 2024
Last Update
April 1 2025
Active Locations (1)
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1
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45267