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

NCT05441592 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00210979
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Keywords

Breast reduction; Gender-affirming mastectomy; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• Hematomas

  Results reflect the number of hematomas that occurred during the trial, requiring operative washout or aspiration in participants who received TXA versus participants who did not receive TXA.

  Up to approximately 4 weeks after surgery

Secondary Outcomes (2)

• Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug

  Up to approximately 4 weeks after surgery

• Participants Who Experienced Major Complications Other Than Hematoma

  Up to approximately 4 weeks after surgery

Study Arms (2)

Irrigation that contains tranexamic acid (TXA)

EXPERIMENTAL

Drug: Tranexamic acid injection

No additional irrigation usual care

OTHER

Other: No additional irrigation

Interventions

Tranexamic acid injection 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.

Irrigation that contains tranexamic acid (TXA)

No additional irrigation OTHER

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

No additional irrigation usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Edwin Wilkins
• Organization: University of Michigan

ewilkins@med.umich.edu

734-936-6680

Study Officials

• Edwin Wilkins, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 1, 2022
• Study Start: August 15, 2022
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)