The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

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

Study Overview

• Status: Withdrawn
• Conditions: Hemorrhage; Eyelid Diseases; Surgical Blood Loss; Periorbital Disorder
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wendy Lee, MD; Phone Number: 305-326-6434; Email: wlee@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute
      • Contact: Wendy W Lee, MD
      • Principal Investigator: Wendy W Lee, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Tranexamic acid; 100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously
Placebo Comparator: 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.	Drug: Placebo; Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously; Other Names: Balanced Saline Solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Wendy W Lee, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Eyelid Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 20220736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No