Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery (NCT07131592) | Clinical Trial Compass
RecruitingPhase 4
Effect of Intravenous and Topical Tranexamic Acid on Drain Output in Breast Reduction Surgery
United States160 participantsStarted 2025-11-18
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total drain output per breast per 24 hours post-surgery (mL) until drain removal
Timeframe: From date of operation until drain removal up to 4 weeks.
2
Time to drain removal (days)
Timeframe: From date of operation until drain removal up to 4 weeks.