The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery (NCT06450392) | Clinical Trial Compass
RecruitingPhase 4
The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
United States150 participantsStarted 2024-10-07
Plain-language summary
Tranexamic acid (TXA) is a synthetic reversible competitive inhibitor to plasminogen lysine receptor, which prevents plasmin formation and stabilizes the fibrin matrix, thus reducing bleeding. While recent studies have demonstrated the antifibrinolytic benefits of TXA in obstetric and gynecologic conditions, traumatic hemorrhage, cardiac surgery, total knee arthroplasty, and more, there is a paucity of clinical data on TXA use in plastic surgery. The aim of this study is to evaluate the effect of local and systemic TXA on postoperative periocular ecchymosis/edema in orbital 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:
* Patients undergoing orbital surgery (decompressions, fracture repairs, enucleations, eviscerations, etc.)
* Patients who are at least 18 years of age
* Patients that have the capacity to consent
Exclusion Criteria:
* Any history of previous orbital surgery
* Any patient undergoing multiple simultaneous periocular surgical procedures
* Any patient with active infection
* History of stroke or seizure
* History of bleeding/clotting disorder
* Patients who do not comply with the required postoperative follow-up schedule
* Patients who are allergic to tranexamic acid
* Patients who have taken anticoagulant/antiplatelet agents (including aspirin) within 7 days prior to surgery
* Patients who have 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.