Intravenous and topical tranexamic acid to reduce drain fluid after breast reduction
Official title: The Effect of Tranexamic Acid on Drainage Volume and Time to Drain Removal in Reduction Mammaplasty Patients
Run by Massachusetts General Hospital · NCT07131592 · Data updated 2026-11-12
This trial will test whether giving tranexamic acid intravenously and placing it in one breast drain during bilateral breast reduction can reduce postoperative drain fluid in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 160 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | March 1, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07131592 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older planning elective bilateral breast reduction who are non-smokers, without bleeding disorders, seizure history, pregnancy, or TXA allergy, and who can provide informed consent and complete follow-up are ideal candidates.
✕Probably not a fit
Patients with prior breast radiation, revision reductions, active smoking, known coagulopathy, history of seizures, pregnancy or breastfeeding, or allergy/contraindication to TXA are excluded and unlikely to receive benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, randomized controlled trial at Massachusetts General Hospital will compare systemic IV tranexamic acid versus no IV during bilateral reduction mammaplasty, while each breast is independently randomized to receive topical tranexamic acid or saline via the closed-suction drain. The split-body design allows direct intra-individual comparison of local topical effects while also evaluating systemic administration. Primary outcomes are total drain output per breast and time to drain removal, with secondary endpoints including postoperative hematoma and patient-reported outcomes. Participants are followed for 30 days with standardized outcome recording and blinded assessment where applicable.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative drain output, shorten time with drains, and lower wound-related complications after breast reduction.
How similar studies have gone: Tranexamic acid is well established to reduce intraoperative bleeding across many surgical fields, but combining IV and topical TXA to reduce postoperative drain output in breast reduction is relatively novel and has limited direct prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older * Elective bilateral breast reduction * Patient understands and is willing to participate in the study * Patient willing to and capable of providing informed consent Exclusion Criteria: * Age less than 18 years old * Prior radiation to the breast * Secondary/Revision breast reduction * Known coagulopathy or bleeding disorders * Intraoperative coagulopathy * History of seizures * Active smokers * Allergy or contraindication to TXA * Pregnant or breastfeeding patients * Patient is unable or unwilling to complete the anticipated study follow-up * Inability to understand the aims and objectives of the study * Inability to or unwilling to provide informed consent
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.