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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Hematoma Postoperative
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Edwin Wilkins, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-06