The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

University of Miami

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Conditions

Eyelid Diseases Periorbital Disorder Hemorrhage Surgical Blood Loss

Interventions

Tranexamic acidDRUG

100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously

PlaceboDRUG

Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Up to 3 months

Secondary Outcomes

Postoperative patient chemosis

Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema)

Time frame: 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.

Time frame: Up to 3 months

Intraoperative patient bleeding

The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials.

Time frame: 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.

Time frame: 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.

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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