Using topical tranexamic acid to prevent hematomas in breast surgery
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
This study tests if using a special medication during breast surgery can help prevent bruising and swelling afterwards for patients undergoing breast reduction or gender-affirming mastectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05441592 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of topical tranexamic acid in reducing the risk of hematomas following breast reduction and gender-affirming mastectomy surgeries. Patients will be randomly assigned to receive either the tranexamic acid treatment or no additional irrigation during their surgical procedure. The study aims to determine the safety and efficacy of this intervention in a controlled setting, focusing on postoperative outcomes related to hematoma formation.
Who should consider this trial
Good fit: Ideal candidates include individuals scheduled for bilateral breast reduction or bilateral gender-affirming mastectomy.
Not a fit: Patients with active thromboembolic disease, hypersensitivity to tranexamic acid, or those currently using systemic anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of hematomas in patients undergoing breast surgery, leading to improved recovery and outcomes.
How similar studies have performed: While the use of tranexamic acid has been explored in various surgical contexts, this specific application in breast surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Edwin Wilkins, MD — University of Michigan
- Study coordinator: Sherry Tang, MD
- Email: syqtang@med.umich.edu
- Phone: 734-936-5895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.