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Anti-fibrinolytic

Tranexamic Acid for Hematoma after Breast Surgery

Phase 3

Waitlist Available

Led By Christopher Coroneos, MD, FRCSC

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are undergoing bilateral breast reduction at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

Are 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial will compare the use of an anti-fibrinolytic (TXA) to a placebo in reducing the incidence of surgical site hematoma following bilateral breast reduction surgery.

Who is the study for?

This trial is for adults over 18 who are having bilateral breast reduction surgery at specified hospitals. It's not for those on blood thinners, pregnant or breastfeeding women, people allergic to TXA, with bleeding disorders, color vision issues, certain types of hemorrhage or hematuria, irregular periods, or seizures.Check my eligibility

What is being tested?

The study tests if applying tranexamic acid (TXA) topically during breast reduction surgery can reduce hematoma compared to a placebo saline solution. One breast gets TXA and the other saline in this blinded study where neither patients nor doctors know which treatment is applied where.See study design

What are the potential side effects?

While the trial focuses on topical application which may limit side effects, systemic absorption of TXA could potentially cause gastrointestinal disturbances, dizziness or headaches. Allergic reactions are possible but should be rare given the exclusion criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having a breast reduction at Hamilton Health Sciences or St. Joseph's Hospital.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hematoma

Seroma

Secondary outcome measures

Days with drains

Drain output

Imaging findings

+2 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Tranexamic AcidExperimental Treatment1 Intervention

3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline

Group II: Normal SalinePlacebo Group1 Intervention

40 mL topical of 0.9% normal saline

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

2018

Completed Phase 4

~42540

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,784 Total Patients Enrolled

2 Trials studying Hematoma

186 Patients Enrolled for Hematoma

Christopher Coroneos, MD, FRCSCPrincipal InvestigatorMcMaster University

Media Library

Tranexamic acid (Anti-fibrinolytic) Clinical Trial Eligibility Overview. Trial Name: NCT04918576 — Phase 3

Hematoma Research Study Groups: Tranexamic Acid, Normal Saline

Hematoma Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT04918576 — Phase 3

Tranexamic acid (Anti-fibrinolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918576 — Phase 3

Frequently Asked Questions

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

What are the investigators of this study hoping to achieve?

"The clinical trial will last for 2 weeks and the primary outcome variable is hematoma size. Other measures that will be taken include the number of days that drains are required, the number of repeat operations due to complications, and total drain output at 24 hours."

Answered by AI

Out of the patients who have signed up for this clinical trial, how many total participants are there?

"This particular study has completed recruitment for participants. However, there are other similar trials that may be of interest. As of now, there are 69 trials for Tranexamic acid that are actively admitting patients."

Answered by AI

Are we still looking for more test subjects for this clinical trial?

"Data from clinicaltrials.gov suggests that this trial is not actively recruiting. This specific study was first posted on August 1st, 2020 and updated most recently on April 4th, 2020. Although this trial is not looking for patients, there are 138 other clinical trials with open recruitment."

Answered by AI

Has the FDA cleared Tranexamic acid for use?

"Tranexamic acid has received a 3 because, as a Phase 3 clinical trial, there is both evidence of efficacy and multiple rounds of safety data."

Answered by AI

Are people aged 60 or older allowed to participate in this clinical trial?

"This study is enrolling individuals who are aged 18 to 99."

Answered by AI

Are there any specific requirements to join this trial?

"This study is testing the effects of tranexamic on 106 individuals aged 18 to 99. The most crucial requirements for participants are as follows: being 18 or older and scheduled for bilateral breast reduction surgery at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton."

Answered by AI

What are some frequent indications for Tranexamic acid?

"Tranexamic acid is frequently used to treat hyperfibrinolysis. This medication can also be taken for a variety of other reasons, such as to manage bleeding for patients with hemophilia or those who have just undergone a tooth extraction."

Answered by AI

Is this the first clinical trial to study Tranexamic acid?

"Right now, there are 69 separate investigations into Tranexamic acid's effectiveness. Of these, 29 are still ongoing and in the third stage of clinical trials. Even though the majority of the trials for this medication are based in one city, Kansas City, Kansas, there are 305 different locations running these studies."

Answered by AI