A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
- Conditions
- Hematoma Postoperative
- Registration Number
- NCT05441592
- Lead Sponsor
- University of Michigan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria:<br><br> - Patients undergoing bilateral breast reduction or bilateral gender-affirming<br> mastectomy<br><br> - For patients undergoing bilateral breast reduction, any skin incision pattern or<br> pedicle is acceptable.<br><br> - For patients undergoing bilateral gender-affirming mastectomy, any skin incision and<br> mastectomy type is acceptable<br><br>Exclusion Criteria:<br><br> - Active thromboembolic disease or history of intrinsic risk of thrombosis or<br> thromboembolism, including retinal vein or artery occlusion<br><br> - Current use of systemic anticoagulation<br><br> - Hypersensitivity to tranexamic acid<br><br> - Concomitant use of combined hormonal contraceptives<br><br> - Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or<br> all-trans retinoic acid<br><br> - History of acquired defective color vision<br><br> - History of subarachnoid hemorrhage<br><br> - Pregnancy<br><br> - History of renal impairment or serum Creatinine >1.5 milligrams per deciliter<br> (mg/dL)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA
- Secondary Outcome Measures
Name Time Method Number of participants experiencing a major thromboembolic event related to the study drug;Number of participants experiencing major complications other than hematoma