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Anti-fibrinolytic
Topical Tranexamic Acid for Reducing Hematoma Risk in Breast Surgery
Phase 4
Recruiting
Led By Edwin Wilkins, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing bilateral breast reduction or bilateral gender-affirming mastectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 weeks after surgery
Awards & highlights
Study Summary
This trial is to see if a medicine can prevent bruises during breast surgery.
Who is the study for?
This trial is for patients undergoing bilateral breast reduction or gender-affirming mastectomy with no restrictions on the type of skin incision or surgery. It's not for those with color vision issues, kidney problems, sensitivity to tranexamic acid, using anticoagulants or certain contraceptives, a history of brain hemorrhage, pregnant women, or anyone at risk of blood clots.Check my eligibility
What is being tested?
The study tests if applying tranexamic acid directly onto the surgical area can prevent bleeding complications like hematomas after breast surgery. Patients are randomly chosen to either receive this treatment or no additional intervention during their procedure.See study design
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea, diarrhea, and possibly increase the risk of blood clots in some individuals. However, when used topically (applied to the skin), these risks might be lower compared to taking it by mouth or injection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having surgery to reduce both breasts or for gender-affirming mastectomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 4 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Hematomas requiring operative washout or aspiration in participants that receive TXA versus participants that do not receive TXA
Secondary outcome measures
Number of participants experiencing a major thromboembolic event related to the study drug
Number of participants experiencing major complications other than hematoma
Side effects data
From 2021 Phase 3 trial • 1226 Patients • NCT047331575%
Vomiting
2%
Dizziness
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Group/Group A_(Tranexamic Acid)
Control Group/Group B_(Placebo)
Trial Design
2Treatment groups
Experimental Treatment
Group I: No additional irrigation usual careExperimental Treatment1 Intervention
Group II: Irrigation that contains tranexamic acid (TXA)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,558 Total Patients Enrolled
Edwin Wilkins, MDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking blood thinners.You are allergic to tranexamic acid.My kidney function is impaired or my creatinine level is above 1.5 mg/dL.I am using specific blood clotting or skin treatment medications.I am having or had a gender-affirming mastectomy with any type of skin incision.I am currently using combined hormonal contraceptives.I have had a bleeding in the space around my brain.I have a current or past history of blood clots, including in the eye.You are pregnant.You have a history of color blindness that you developed later in life.I am having surgery to reduce both breasts or for gender-affirming mastectomy.I am having a breast reduction and any surgical method is okay.
Research Study Groups:
This trial has the following groups:- Group 1: Irrigation that contains tranexamic acid (TXA)
- Group 2: No additional irrigation usual care
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for volunteers to join the research?
"Affirmative. Per the information presented onclinicaltrials.gov, this experiment has been recruiting since August 15th 2022 and is presently seeking 500 participants from one medical centre."
Answered by AI
What is the total number of participants enrolled in this research project?
"Confirmed, the information on clinicaltrials.gov declares that this medical trial is currently seeking recruits. Initially posted on August 15th 2022, it has had edits up to and including August 17th 2022. The study requires 500 patients from a single location for participation."
Answered by AI
Is the injection of Tranexamic acid a secure treatment for patients?
"The safety of Tranexamic acid injection is ranked 3, as this drug has been approved for use in a Phase 4 trial."
Answered by AI
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