The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Study Overview
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Brief Summary
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This study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.

Official Title
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The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Conditions
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Eyelid Diseases, Periorbital Disorder, Hemorrhage, Surgical Blood Loss

Intervention / Treatment
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* Drug: Tranexamic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR). Exclusion Criteria: - Adults unable to consent Individuals less than 18 years of age Prisoners Pregnant women. Known contradictions or sensitivities to study medication (tranexamic acid) Patients with known prior thromboembolic events Previous eyelid surgery or same-side DCR (RE-DCR) Has any type of coagulopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic Acid Group<br>Participants undergoing standard of care periorbital procedures will be randomized to receive tranexamic acid with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision. | Drug: Tranexamic acid<br>* 100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously<br>|
| Placebo Comparator: Placebo Group<br>Participants undergoing standard of care periorbital procedures will be randomized to receive balanced salt solution with lidocaine/epinephrine on one of their eyelids at the beginning of the scheduled operation before incision. | Drug: Placebo<br>* Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously<br>* Other names: Balanced Saline Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative patient ecchymosis | Ecchymosis will be graded 0-3 based on location and degree based on a previously reported validated scale (higher scores with more ecchymosis) | Up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative patient chemosis | Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema) | Up to 3 months | 
| Eyelid edema | Measurement includes through Surgeon Periorbital Ration of Edema and Ecchymosis (SPREE), which has a total score ranging from 1 to 4 with the higher score indicating more severe eyelid edema. | Up to 3 months | 
| Intraoperative patient bleeding | The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials. | Postoperative day 0 (day of surgery) | 
| Physician Perception of Intraoperative Bleeding | The primary surgeon will subjectively rank the efficacy of hemostasis on a scale of 1-4 [excellent (1), good (2), moderate (3), or poor (4) ] immediately after the operation. | Postoperative day 0 (day of surgery) | 
| Patient-perceived outcomes | Patients will complete a validated FACE-Q survey which has a raw score converted to a scaled score of from 0-100, with higher scores indicating a better outcome. | Up to 3 months |