← Back to Search

Anti-fibrinolytic

Tranexamic Acid for Breast Reconstruction

Phase 3

Waitlist Available

Led By Ronen Avram, 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 one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy 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 tranexamic acid to a placebo in alloplastic breast reconstruction to see if it reduces the incidence of surgical site hematoma.

Who is the study for?

This trial is for adults over 18 who are having bilateral alloplastic breast reconstruction right after a mastectomy at specific hospitals. It's not for those on blood thinners, pregnant or breastfeeding women, anyone allergic to TXA, with certain bleeding disorders or vision problems, irregular periods, urinary bleeding, seizures, or unable to consent.Check my eligibility

What is being tested?

The study tests if applying tranexamic acid (TXA) topically during surgery can reduce hematoma compared to a saline placebo. Each patient's one breast gets TXA and the other saline in this blinded study to see which works better within two weeks post-surgery.See study design

What are the potential side effects?

Tranexamic acid may cause side effects like nausea, diarrhea, dizziness; rarely it could lead to more serious issues such as blood clots or allergic reactions. The normal saline used as a placebo typically doesn't have side effects.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having immediate breast reconstruction with implants after a bilateral mastectomy at Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

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 (30 mL 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

Ronen Avram, MD, FRCSCPrincipal InvestigatorMcMaster University

Media Library

Tranexamic acid (Anti-fibrinolytic) Clinical Trial Eligibility Overview. Trial Name: NCT04918589 — Phase 3

Hematoma Research Study Groups: Tranexamic Acid, Normal Saline

Hematoma Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT04918589 — Phase 3

Tranexamic acid (Anti-fibrinolytic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918589 — Phase 3

Frequently Asked Questions

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

Can you share what Tranexamic acid is commonly employed to treat?

"Tranexamic acid is a medication used to treat hyperfibrinolysis. This drug can also be used to medicine other conditions, such as hemophilia and tooth extractions that result in bleeding."

Answered by AI

Who meets the age requirements for participating in this research project?

"This trial is for patients aged 18 to 99. If you are looking for a clinical trial for someone who falls outside of that age range, there are 62 options for those under 18 and 1498 options for those over 65."

Answered by AI

What do we know about Tranexamic acid from other medical research?

"As of right now, there are 68 ongoing studies involving Tranexamic acid. Out of those, 29 are in the final stage of testing before approval. The majority of these clinical trials are based in Kaohsiung City, Yanchao District; however, there are a total of 304 research sites running these tests worldwide."

Answered by AI

What are the main goals that researchers are hoping to achieve through this study?

"The objective of this 2 week clinical trial is to study Seroma. Additionally, this medical research will also observe secondary outcomes like Ultrasound findings of hematoma or seroma and the number of repeat operations needed for patients related to complications."

Answered by AI

If I qualify, how can I enroll in this research study?

"This trial is recruiting 106 patients who have tranexamic acid and are between the ages of 18 and 99. To be eligible, patients must also meet the following criteria:-Are undergoing one- or two-stage bilateral alloplastic breast reconstruction immediately after bilateral mastectomy at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.-Are 18 years or older."

Answered by AI

Is Tranexamic acid likely to cause any adverse effects for patients?

"There is already some evidence of tranexamic acid's efficacy, as well as numerous rounds of data affirming its safety. Consequently, we have given it a score of 3."

Answered by AI

Are there still places available for volunteers in this clinical trial?

"Unfortunately, this clinical trial is not enrolling new patients at the moment. However, there are 1513 other clinical trials that are currently enrolling patients who are taking tranexamic acid. Additionally, there are 68 other trials that are actively recruiting participants for Tranexamic acid."

Answered by AI