Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06450392

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

Led by Montefiore Medical Center · Updated on 2025-12-16

150

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

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Research Team

A

Anne Barmettler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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