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

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent

Exclusion Criteria:

* Any history of previous orbital surgery
* Any patient undergoing multiple simultaneous periocular surgical procedures
* Any patient with active infection
* History of stroke or seizure
* History of bleeding/clotting disorder
* Patients who do not comply with the required postoperative follow-up schedule
* Patients who are allergic to tranexamic acid
* Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
* Patients who have periocular ecchymosis or edema prior to surgery

About the study

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.

What is being tested

• Tranexamic acid injection (drug)
• Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML) (drug)
• normal saline - injection (drug)
• normal saline - intravenous (drug)

Sponsor: Montefiore Medical Center · Participants: 150 · Started: Oct 7, 2024

Contact the study team

• Anne Barmettler · Phone: 718-920-4609

Official record on ClinicalTrials.gov — NCT06450392

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.