The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-06-01

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.

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Detailed Description

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Conditions

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Eyelid Diseases Periorbital Disorder Hemorrhage Surgical Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tranexamic Acid Group

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.

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

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

Placebo Group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Tranexamic acid

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Balanced Saline Solution

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No