NCT06450392

The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in 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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 prior to incision. Group 3: will receive intravenous normal saline and subcutaneous local anesthetic (i.e. standard procedure) as control group. Twenty minutes before incision time, all patients will receive an intravenous solution. This will be either saline (placebo, participants in group 2 and 3) or 1g of tranexamic acid (participants in group 1). All operations will be performed using the standard of care technique and surgical instruments. All surgery will be performed under intravenous sedation with local anesthesia. Standard skin marking will be drawn, then the surgeon will inject each patient subcutaneously with either (1) a 5 cc mixture of TXA (100 mg/mL) mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (local TXA, Group 2) or (2) normal saline 0.9% sodium chloride mixed with 2% lidocaine with epinephrine and 0.5% marcaine with epinephrine in a 1:1:1 ratio (Group 1, Group 3). Degree of ecchymosis and edema in the postoperative photographs will be assessed separately by two graders. Graders will be blinded to treatment groups, and the photos will be completely deidentified. Immediately following the procedure, the surgeon will take standardized photographs. The surgeon will also take standardized photographs at the regular 7-day postoperative visit. These photos will be deidentified and analyzed for degree of ecchymosis and edema by two blinded graders who will rate the photos using a standard five point grading scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) as described in the respective outcome measures.

Conditions

• Orbital Edema
• Orbital Ecchymosis

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	100 mg/mL (manufactured concentration) local TXA injection in the orbit
DRUG	Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)	1g IV TXA
DRUG	normal saline - injection	0.9% Normal Saline injection in the orbit
DRUG	normal saline - intravenous	0.9% IV Normal Saline

Timeline

• Start date: 2024-10-07
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-06-10
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study