Phase 4
N=98
Use of Tranexamic Acid in Reduction Mammoplasty
Hematoma Postoperative · Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT04947514 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Breasts With Development of Hematoma — 2; 1 breasts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tranexamic acid (Drug); Placebo (topical saline) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Breasts With Development of Hematoma |
2; 1 | — |
| SECONDARY Number of Participants Requiring a Blood Transfusion |
0; 0 | — |
| SECONDARY Number of Participants With Deep Vein Thrombosis/Venous Thromboembolism |
0; 0 | — |
Summary
Breast reduction mammoplasty (BRM) is among the most commonly performed procedures in plastic surgery. However, postoperative hematoma is one of the most common complications following BRM. Hematoma-related complications include unplanned surgery, need for blood transfusion, wound healing issues, and unfavorable surgical outcomes.
Tranexamic acid has emerged in the literature as a promising agent that reduces perioperative blood loss and need for transfusion. However, despite its consistently reported efficacy, low cost, and favorable safety profile, tranexamic acid remains underutilized in plastic surgery.
The investigators propose a prospective, double-blinded randomized controlled study of the efficacy of tranexamic acid in reducing hematoma development in patients undergoing reduction mammoplasty. The investigators hope to contribute to the growing body of literature supporting tranexamic acid to reduce unwanted surgical bleeding.
Eligibility Criteria
Inclusion Criteria
- Being over the age of 18
- Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York
Exclusion Criteria
- Oncologic breast reduction
- Unilateral breast reduction
- History of thromboembolic disease
- History of bleeding diatheses
- History of stroke
- History of seizure disorder
- Currently pregnant
- Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness grade IV or above)
Data sourced from ClinicalTrials.gov (NCT04947514). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.