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

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.

Study Overview

• Status: Completed
• Conditions: Hematoma Postoperative
• Intervention / Treatment: Drug: Tranexamic acid injection; Other: No additional irrigation

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irrigation that contains tranexamic acid (TXA)	Drug: 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.
Other: No additional irrigation usual care	Other: No additional irrigation; There will be no additional irrigation after the standard surgical procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug	Results reflect the number of participants who experienced any major thromboembolic event during the trial. Major thromboembolic events included, but were not limited to, deep vein thrombosis, pulmonary embolism, and stroke.	Up to approximately 4 weeks after surgery
Participants Who Experienced Major Complications Other Than Hematoma	Results reflect the number of participants who experienced any major complication other than a hematoma. Major complications included, but were not limited to, infection, seroma, hypersensitivity reaction to TXA, and renal impairment.	Up to approximately 4 weeks after surgery

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Edwin Wilkins, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): July 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Tranexamic Acid; Breast reduction; Gender-affirming mastectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma; Organic Chemicals; Carboxylic Acids; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Tranexamic Acid
• Other Study ID Numbers: HUM00210979

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No