The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial
Montefiore Medical Center
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.
Description
Patients, who will be undergoing orbital surgery anyways, will be given the option to participate in the study. Informed consent will be obtained in clinic during the preoperative consultation. On the day of surgery in the preoperative suite, study participants will be randomly allocated to one of three groups via computer-generated random numbers: Group 1: will receive 1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery. Group 2: will receive 1.7 mL of subcutaneous tranexamic acid 100 mg/mL (Pfizer, New York, NY) with local anesthetic to the orbit two minutes pr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * Pati…
Interventions
- DrugTranexamic acid injection
100 mg/mL (manufactured concentration) local TXA injection in the orbit
- DrugTranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)
1g IV TXA
- Drugnormal saline - injection
0.9% Normal Saline injection in the orbit
- Drugnormal saline - intravenous
0.9% IV Normal Saline
Location
- Montefiore Medical CenterThe Bronx, New York