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

Phase 4

Recruiting

• Conditions: Orbital Edema; Orbital Ecchymosis
• Interventions: Drug: Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML); Drug: normal saline - injection; Drug: Tranexamic acid injection; Drug: normal saline - intravenous

• Registration Number: NCT06450392
• Lead Sponsor: Montefiore Medical Center

Brief Summary

Tranexamic acid 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.

Study Timeline

• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-10
• Study Start: 2024-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Control	normal saline - intravenous	Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group
Group 1: IV TXA	Tranexamic Acid in NaCl,Iso-Os 1,000 Mg/100 mL (10 Mg/mL) INTRAVEN INTRAVENOUS SOLUTION, PIGGYBACK (ML)	1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery
Group 3: Control	normal saline - injection	Normal saline and subcutaneous local anesthetic to both eyelids (i.e. standard procedure) as control group
Group 1: IV TXA	normal saline - injection	1g intravenous tranexamic acid (Pfizer, New York, NY) 20 minutes prior to surgery
Group 2: Local TXA	normal saline - intravenous	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
Group 2: Local TXA	Tranexamic acid injection	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

Primary Outcome Measures

Name	Time	Method
Degree of Ecchymosis	0 days and 7 days postoperatively	Degree of ecchymosis on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of ecchymosis.
Degree of Edema	0 days and 7 days postoperatively	Degree of edema on postoperative day zero (POD0) and postoperative day 7 (POD7) as graded on a 5 point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = profound) by two independent graders. The two scores will be averaged for inclusion in analysis. Scores will be aggregated to calculate means and standard deviations (SDs) for each group. Higher scores are associated with increased severity of edema.

Secondary Outcome Measures

Name	Time	Method
Other side effects	7 days postoperatively	Patients will be asked if they had any seizure, focal weakness, lower extremity pain, difficulty breathing, chest pain, or any emergency room visit (to assess for adverse effects including thromboembolic event or seizure). Responses will be recorded as either "Thromboembolic event occurred" or "Thromboembolic event did not occur." Seizure events will be recorded in the same way. The number of patients with thromboembolic events and/or seizures will be summarized by the study arm.
Patient Satisfaction with edema	7 days postoperatively	Patients asked how satisfied they are with their edema postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.
Patient Satisfaction with ecchymosis	7 days postoperatively	Patients asked how satisfied they are with their ecchymosis postoperatively. Responses will be scored as 0 (not satisfied at all), 1 (somewhat unsatisfied), 2 (neutral), 3 (somewhat satisfied), or 4 (completely satisfied). Responses will be summed and mean scores and standard deviations (SDs) will be reported for each group. Higher scores correlate with increased degree of satisfaction.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States