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Antifibrinolytic

Tranexamic Acid for Breast Surgery Recovery

Phase 2
Recruiting
Led By Robert L Walton, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Scheduled or plans to schedule a bilateral mastectomy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 month post-operatively
Awards & highlights

Study Summary

This trial is testing whether using a drug that prevents blood clot breakdown topically during surgery can reduce post-operative healing time and events such as bleeding and fluid accumulation.

Who is the study for?
This trial is for women over 18 planning a bilateral mastectomy to prevent breast cancer. They must understand and sign the consent form. It's not for those allergic to Tranexamic acid (TxA), with clotting disorders, on long-term dialysis, recent brain hemorrhage, or previous mastectomies.Check my eligibility
What is being tested?
The study tests if applying TxA topically during surgery can reduce post-mastectomy fluid accumulation and bleeding, potentially shortening the time drains are needed. One breast will be treated with TxA while the other gets saline as a comparison.See study design
What are the potential side effects?
While TxA is generally used in other surgeries, potential side effects may include discomfort at application site or allergic reactions in sensitive individuals; however, it's known for its blood clot-promoting properties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am planning to have both of my breasts surgically removed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 month post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 month post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Drain output
Secondary outcome measures
Safety evaluation

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116
22%
Readmissions
14%
Postoperative infections
10%
Re-operations
4%
Thromboembolic events
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Group
Tranexamic Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental BreastExperimental Treatment1 Intervention
Participants will receive 50 ml of TxA and gentamicin to the assigned experimental breast.
Group II: Control BreastPlacebo Group1 Intervention
Participants will receive a standard irrigation of 50 ml of 0.9% NS and gentamicin to the assigned control breast.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
2018
Completed Phase 4
~42540

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,755 Total Patients Enrolled
38 Trials studying Breast Cancer
12,445 Patients Enrolled for Breast Cancer
Saint Joseph Hospital, Chicago, IllinoisOTHER
Northwestern Memorial HospitalOTHER
40 Previous Clinical Trials
16,686 Total Patients Enrolled
1 Trials studying Breast Cancer
4,436 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are younger patients within the age limit of this research trial?

"The age requirement to participate in this study is between 18 and 80 years old."

Answered by AI

Could I possibly take part in this research project?

"Eligible patients for this trial must be female, aged 18 or older, with scheduled plans for a bilateral mastectomy. In addition, all participants much be able to understand the study's informed consent form and sign it of their own accord."

Answered by AI

Are there any available positions for candidates in this program?

"Yes, the information on clinicaltrials.gov suggests that this clinical trial is actively seeking candidates. The study was initially posted on 7/12/2022 and was last updated on 9/21/2022. The trial is admitting 30 patients across 2 sites."

Answered by AI

Has the FDA cleared Experimental Breast for use?

"While there is some evidence to support the safety of Experimental Breast, it received a score of 2 because this is only supported by data from Phase 2 trials."

Answered by AI

What is the total number of enrollees in this clinical trial?

"Yes, this is an active recruitment according to the information available on clinicaltrials.gov. The trial was first posted on 7/12/2022 and has been updated as recently as 9/21/2022. They are looking for 30 patients from 2 locations."

Answered by AI
~9 spots leftby Dec 2024