A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)