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New treatment option for Orbital Edema
Official title The Effect of Local and Systemic Tranexamic Acid on Edema and Ecchymosis in Orbital Surgery
ClinicalTrials.gov ID: NCT06450392
What this study is testing
What is Tranexamic acid injection?
Tranexamic acid injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for orbital edema.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.