The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Hemorrhage Clinical Trial

Official title:

The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05672407
• Other study ID #: 20220736
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Eyelid Diseases
• Hemorrhage
• Periorbital Disorder
• Surgical Blood Loss

Intervention

Drug:
• Tranexamic acid
100 mg/mL Tranexamic acid with lidocaine with 1:100,000 epinephrine in 1:1 manner administered subcutaneously
• Placebo
Lidocaine with 1:100,000 epinephrine mixed with 1:1 Basal Saline Solution (BSS) administered subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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