The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery

University of Miami

Status and phase: Withdrawn; Phase 4

Conditions: Surgical Blood Loss; Hemorrhage; Periorbital Disorder; Eyelid Diseases

Treatments: Drug: Placebo; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT05672407

20220736

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Tranexamic Acid Group

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic acid

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo