Status:
COMPLETED
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Lead Sponsor:
University of Michigan
Conditions:
Hematoma Postoperative
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is being completed to evaluate the safety and efficacy of topical tranexamic acid use in preventing hematomas in routine breast plastic surgery operations.
Eligibility Criteria
Inclusion
- Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
- For patients undergoing bilateral breast reduction, any skin incision pattern or pedicle is acceptable.
- For patients undergoing bilateral gender-affirming mastectomy, any skin incision and mastectomy type is acceptable
Exclusion
- Active thromboembolic disease or history of intrinsic risk of thrombosis or thromboembolism, including retinal vein or artery occlusion
- Current use of systemic anticoagulation
- Hypersensitivity to tranexamic acid
- Concomitant use of combined hormonal contraceptives
- Use of factor IX complex concentrates, anti-inhibitor coagulant concentrates or all-trans retinoic acid
- History of acquired defective color vision
- History of subarachnoid hemorrhage
- Pregnancy
- History of renal impairment or serum Creatinine \>1.5 milligrams per deciliter (mg/dL)
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2024
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT05441592
Start Date
August 15 2022
End Date
October 22 2024
Last Update
November 26 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109