The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Phase 4

Withdrawn

• Conditions: Eyelid Diseases; Periorbital Disorder; Hemorrhage; Surgical Blood Loss
• Interventions: Drug: Placebo; Drug: Tranexamic acid

• Registration Number: NCT05672407
• Lead Sponsor: University of Miami

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Study First Posted: 2023-01-05
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Last Update Submitted: 2023-09-15
• Last Update Posted: 2023-09-21
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	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.
Tranexamic Acid Group	Tranexamic acid	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Postoperative patient chemosis	Up to 3 months	Chemosis, swelling of the eyes, will be measured on a scale of 0-4 (higher scores, more edema)
Patient-perceived outcomes	Up to 3 months	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.
Eyelid edema	Up to 3 months	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.
Intraoperative patient bleeding	Postoperative day 0 (day of surgery)	The amount of blood loss intraoperatively will be measured using a scale for blood soaked materials.
Physician Perception of Intraoperative Bleeding	Postoperative day 0 (day of surgery)	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.