The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surger
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
| Condition(s) | Orbital Edema, Orbital Ecchymosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Montefiore Medical Center |
| Locations | The Bronx, New York, United States |
| Start date | 2024-10-07 |
| NCT ID | NCT06450392 |
| Official listing | https://clinicaltrials.gov/study/NCT06450392 |