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Completed

NCT Number: NCT05441592

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.

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Key information

Conditions

Hematoma Postoperative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

No additional irrigation

Other

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

Primary outcomes

  1. Hematomas

    Time frame: Up to approximately 4 weeks after surgery

    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.

Secondary outcomes

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

    Time frame: Up to approximately 4 weeks after surgery

    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.

  2. Participants Who Experienced Major Complications Other Than Hematoma

    Time frame: Up to approximately 4 weeks after surgery

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 1, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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