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

NCT ID: NCT05441592

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-10-22

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.

Conditions

Hematoma Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Irrigation that contains tranexamic acid (TXA)

Group Type: EXPERIMENTAL

Tranexamic acid injection

Intervention Type: DRUG

The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.

No additional irrigation usual care

Group Type: OTHER

No additional irrigation

Intervention Type: OTHER

There will be no additional irrigation after the standard surgical procedure.

Interventions

Tranexamic acid injection

The breast pockets will additionally be irrigated with 150 cc of 2.67% TXA (75 cc in each breast). The TXA solution will be allowed to be sit in the breast pocket for 15 minutes and then removed after 15 minutes.

Intervention Type: DRUG

No additional irrigation

There will be no additional irrigation after the standard surgical procedure.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Edwin G. Wilkins

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edwin Wilkins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00210979

Identifier Type: -

Identifier Source: org_study_id