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Tranexamic Acid for Breast Reconstruction
Study Summary
This trial will study if using tranexamic acid in breast surgery can reduce bruising, bleeding, fluid build-up, and improve patient satisfaction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently taking blood thinners.I am currently taking chlorpromazine.I am scheduled for a bilateral mastectomy with reconstruction.I have a history of blood clots.I am male.I am 18 years old or older.It has been over 4 weeks since I finished my chemotherapy or radiation therapy.I have been diagnosed with breast cancer or am at high risk for it.I am not using any medications that increase the risk of blood clots.
- Group 1: TXA, Saline
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How does the safety profile of TXA, Saline compare to other treatments?
"With the completion of Phase 4 trials, TXA-Saline has been granted approval for use. Considering its safety profile, our team at Power rates it a 3 on a scale from 1 to 3."
Are participants still being recruited for this research endeavor?
"As indicated on the clinicaltrials.gov webpage, this trial is actively recruiting for participants. The first posting was made on March 1st 2023 and the most recent update was released on March 29th of that same year."
How many individuals are participating in this investigation?
"Affirmative. The clinical trial, initially made available on March 1st 2023, is still accepting participants according to the details posted on clinicaltrials.gov. 150 individuals are sought from one single site for this experiment."
What aims is this trial hoping to accomplish?
"The primary aim of this three-month clinical trial is to quantify the amount of participants with hematoma. Secondary goals are to measure median total drain output, which entails calculating the volume produced by drains from insertion in an operating room until discharge on postoperative day one; monitor median total drain duration, or how long it takes for a drainage device to be removed after being inserted; and record the number of patients who need reoperation due to their bilateral mastectomy."
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