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TXA Epi Study


Title The effect of local tranexamic acid on post-operative ecchymosis in eyelid surgery
Therapeutic Area Surgical and Pressure Related Wounds, Eyelid Drooping
Principal Investigator Alison Callahan
Min Age 18 Years
Max Age 85 Years
Gender Any
Contact Yi Ling Dai
781-472-9802
ydai@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04951128

Overview

This is a multisite, randomized controlled clinical trial evaluating the effect of local tranexamic acid on post-operative ecchymosis in eyelid surgery. Patients will act as their own controls with one eyelid receiving a control injection of standard local anesthetic whereas the other eyelid will be randomized to receive a mixture of local anesthetic and tranexamic acid. Post-operative ecchymosis will be graded by a masked reviewer using a validated scale.

Study Details

Inclusion Criteria

1. any patient >18 years of age < 85 years of age
2. have consented for upper/lower eyelid blepharoplasty (both cosmetic and/or functional)
3. additional co-current forehead/brow or upper/lower eyelid surgeries may be included

Exclusion Criteria

1. systolic BP > 180 on day of surgery
2. patients who are currently pregnant
3. anticoagulant/antiplatelet use within 7 days of surgery

Study Requirements

Patients will require at least 4 visits, 3 of which will be office visits and 1 will be for the surgery. All of these clinical encounters are necessary for the surgical evaluation and post-operative management of eyelid surgeries and therefore do not occur as stand-alone research visits. Patients will participate in the study up to 1 month after surgery, which is the last post-operative follow up visit. Only photographs will be taken pre- and post- surgery, which is part of the standard of care. No blood or tissue collection will be needed. No additional imaging studies are needed.