Phase 4
Completed N=107
A Randomized Control Trial Assessing the Effect of Topical Tranexamic Acid on Risk of Hematoma in Breast Surgery
Hematoma Postoperative
Source: ClinicalTrials.gov NCT05441592 ↗
Enrolled (actual)
107
Serious AEs
0.9%
Results posted
Nov 2025
Primary outcomePrimary: Hematomas — 0; 1 hematomas — p=0.486
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematomas |
0; 1 | 0.486 |
| SECONDARY Participants Who Experienced a Major Thromboembolic Event Related to the Study Drug |
0; 0 | — |
| SECONDARY Participants Who Experienced Major Complications Other Than Hematoma |
0; 2 | 0.234 |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT05441592). 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. Informational only — not medical advice.