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RECRUITING
NCT06450392
PHASE4

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Tranexamic acid injection

100 mg/mL (manufactured concentration) local TXA injection in the orbit

DRUG

Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)

1g IV TXA

DRUG

normal saline - injection

0.9% Normal Saline injection in the orbit

DRUG

normal saline - intravenous

0.9% IV Normal Saline

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States