Using tranexamic acid to reduce swelling and bruising after 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
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06450392 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for orbital surgery and can provide informed consent.
Not a fit: Patients with a history of previous orbital surgery, active infections, or bleeding disorders may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.