Using tranexamic acid to reduce swelling and bruising after 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
Run by Montefiore Medical Center · NCT06450392 · Data updated 2026-11-12
This study is testing if giving tranexamic acid before orbital surgery can help reduce swelling and bruising for patients after their operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | October 7, 2024 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT06450392 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled for orbital surgery and can provide informed consent.
✕Probably not a fit
Patients with a history of previous orbital surgery, active infections, or bleeding disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of local and systemic administration of tranexamic acid (TXA) on postoperative edema and ecchymosis in patients undergoing orbital surgery. Participants will be randomly assigned to receive either intravenous TXA, subcutaneous TXA, or a placebo saline solution prior to surgery. The aim is to determine if TXA can effectively minimize swelling and bruising associated with these surgical procedures. The study will involve standard surgical techniques and postoperative follow-up to assess outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative swelling and bruising for patients undergoing orbital surgery.
How similar studies have gone: While there is limited data on the use of TXA in plastic surgery, other studies have shown its effectiveness in reducing bleeding in various surgical contexts, suggesting potential for success in this application.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Anne Barmettler — Montefiore Medical Center/Albert Einstein College of Medicine
- Study coordinator: Anne Barmettler
- Email: abarmett@montefiore.org
- Phone: 718-920-4609
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.