The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery - a Prospective, Multicenter, Randomized, Double-blinded, Control Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Anne Barmettler
abarmett@montefiore.org
718-920-4609
Time Frame
Start Date: 2024-10-07
Estimated Completion Date: 2027-01
Participants
Target number of participants: 150
Treatments
Experimental: Group 1: IV TXA
1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery
Experimental: Group 2: Local TXA
1-2mL of subcutaneous tranexamic acid 100 mg/mL (manufactured concentration, Pfizer, New York, NY) mixed with local anesthetic to the orbit two minutes prior to incision
Placebo_comparator: Group 3: Control
Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov