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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 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
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: 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

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
891 Previous Clinical Trials
2,605,360 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
~9 spots leftby Aug 2024
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