UnknownPhase 4

The Effect of Local Tranexamic Acid on Post-operative Edema and Ecchymosis in Eyelid Surgery

United States50 participantsStarted 2021-08-01

Plain-language summary

Tranexamic acid (TXA) is a synthetic inhibitor of plasminogen lysine receptor that has used to reduce intra-operative bleeding in a number of clinical scenarios. Anecdotally, TXA has used by plastic surgeons to reduce post-operative bruising. To date, there is limited data to valid the benefits and to evaluate the side effects of TXA. The objective of this study is to evaluate the effect of local TXA on edema and ecchymosis in eyelid surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Older than 18 years old * Undergo bilateral upper/lower eyelid blepharoplasty, bilateral upper eyelid ptosis repair, or a combination of the above procedures * Additional concurrent forehead/brow or upper/lower eyelids surgeries may be included if bilateral Exclusion Criteria: * Prior eyelid surgery * Anticoagulant or antiplatelet use, including aspirin, within 7 days prior to surgery * Patient who is currently pregnant or breast feeding * Patient with color vision deficiency * TXA allergy * History of bleeding disorder * History of clotting disorder * History of seizure * Have active nausea/vomiting/gastrointestinal symptoms * Have active intracranial bleeding * Have active periocular ecchymosis or edema prior to surgery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Post-operative edema/ecchymosis

Timeframe: 1st post op visit: post-op day 1 to 3

Post-operative edema/ecchymosis

Timeframe: 2nd post op visit: post-op day 7 to 10

Trial details

NCT IDNCT04951128

SponsorConsultants in Ophthalmic and Facial Plastics Surgery

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

Thai Do, MD

248-357-5100 tdo@facialworks.com

View on ClinicalTrials.gov More Edema trials