NCT07131592 · Massachusetts General Hospital
Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery
What this study is about
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either given through a vein (IV) TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline.
View original scientific description
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either intravenous TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline. This approach allows to compare the effects of TXA on fluid buildup and healing. The goal is to improve recovery and reduce complications after breast reduction surgery.
Interventions
DRUG
IV TXA
Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).
DRUG
Topical TXA
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
DRUG
Topical saline
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
Primary outcome measures
Total drain output per breast per 24 hours post-surgery (mL) until drain removal
Time frame: From date of operation until drain removal up to 4 weeks.
Drain outputs will be recorded separately for each breast twice daily until removal.
Time to drain removal (days)
Time frame: From date of operation until drain removal up to 4 weeks.
Drains will be removed per standard protocol by trained staff if the output is ≤30 mL in a 24-hour period for two consecutive days. The time to drain removal will be recorded.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations