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

University of Michigan

Status and phase: Enrolling; Phase 4

Conditions: Hematoma Postoperative

Treatments: Drug: Tranexamic acid injection; Other: No additional irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT05441592

HUM00210979

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

500 participants in 2 patient groups

Irrigation that contains tranexamic acid (TXA)

Experimental group

Treatment:

Drug: Tranexamic acid injection

No additional irrigation usual care

Other group

Treatment:

Other: No additional irrigation