The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

NCT05672407 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20220736
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Eyelid Diseases; Periorbital Disorder; Hemorrhage; Surgical Blood Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative patient chemosis

  Up to 3 months

• Eyelid edema

  Up to 3 months

• Intraoperative patient bleeding

  Postoperative day 0 (day of surgery)

• Physician Perception of Intraoperative Bleeding

  Postoperative day 0 (day of surgery)

• Patient-perceived outcomes

  Up to 3 months

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Tranexamic acid DRUG

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

Tranexamic Acid Group

Placebo DRUG

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

Also known as: Balanced Saline Solution

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (DCR).

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Eyelid Diseases; Hemorrhage; Blood Loss, Surgical

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Wendy W Lee, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Ophthalmology

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 5, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share