The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05672407

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Eyelid Diseases Periorbital Disorder Hemorrhage Surgical Blood Loss	Drug: Tranexamic acid Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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)
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Bascom Palmer Eye Institute	Miami	Florida	United States	33136

Sponsors and Collaborators

University of Miami

Investigators

Principal Investigator: Wendy W Lee, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wendy Lee, Professor of Clinical Ophthalmology, University of Miami

ClinicalTrials.gov Identifier:

NCT05672407

Other Study ID Numbers:

20220736

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 25, 2023