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The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
Sponsor: Montefiore Medical Center
Summary
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital surgery.
Official title: The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-10-07
Completion Date
2027-01
Last Updated
2025-12-16
Healthy Volunteers
No
Conditions
Interventions
Tranexamic acid injection
100 mg/mL (manufactured concentration) local TXA injection in the orbit
Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)
1g IV TXA
normal saline - injection
0.9% Normal Saline injection in the orbit
normal saline - intravenous
0.9% IV Normal Saline
Locations (1)
Montefiore Medical Center
The Bronx, New York, United States