What side effects are associated with this type of intervention?

Tranexamic acid (TXA), an anti-fibrinolytic agent commonly used to reduce bleeding, has several known side effects. These include nausea, vomiting, diarrhea, and, in rare cases, thromboembolic events such as deep vein thrombosis or pulmonary embolism. Other treatments for hematoma, such as surgical drainage, can carry risks of infection, bleeding, and anesthesia-related complications. Overall, while TXA is generally well-tolerated, it is important to monitor for potential adverse effects, especially in patients with a history of thromboembolic disorders.

What prior FDA approvals exist?

Tranexamic Acid (TXA) is an anti-fibrinolytic agent that has been studied for its efficacy in reducing post-surgical bleeding complications, such as hematoma, in various surgical procedures. While the provided context does not specify prior FDA approvals for TXA specifically for hematoma treatment, TXA is widely used and approved for reducing bleeding in surgeries, including orthopedic and breast reconstruction surgeries. Other related drugs in the anti-fibrinolytic category include aminocaproic acid, which also works by inhibiting fibrinolysis to reduce bleeding. These agents are commonly used in clinical practice to manage and prevent excessive bleeding during and after surgical procedures.

What other types of research exist?

Promising novel alternatives to Tranexamic Acid for hematoma patients in 2024 may include anti-TFPI (Tissue Factor Pathway Inhibitor) antibodies like concizumab, which have shown efficacy in reducing bleeding in hemophilia patients. Additionally, bispecific antibodies such as Mim8, which mimic factor VIIIa, are also being developed and may offer new therapeutic options for managing bleeding complications.

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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

Must not have

Have irregular menstrual bleeding

Taking antiplatelet drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Pivotal Trial

Summary

This trial is testing if applying TXA to surgical wounds can reduce bleeding in patients having breast reconstruction surgery. TXA helps keep blood clots intact longer, which may lower the risk of post-surgery bleeding. The study aims to determine the effectiveness of TXA. Tranexamic acid (TXA) has been shown to reduce blood loss and the need for transfusions in various types of surgeries without increasing other risks.

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.

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.

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

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I experience irregular periods.

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I am currently taking medication to prevent blood clots.

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I have blood in my urine.

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I am on blood thinners for treatment.

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I have had a bleeding in the space around my brain.

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I have a diagnosed bleeding disorder.

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I have a condition that causes seizures.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hematoma

Seroma

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tranexamic Acid (TXA) is an anti-fibrinolytic agent that inhibits the conversion of plasminogen to plasmin, an enzyme that breaks down fibrin clots. This action helps stabilize blood clots and prevent excessive bleeding. For hematoma patients, this is particularly important as it reduces the risk of hematoma formation, minimizes pain and discomfort, and can lead to a quicker recovery with fewer complications. By effectively controlling bleeding, TXA and similar treatments play a critical role in improving patient outcomes.

Tranexamic acid for control of haemorrhage in acute promyelocytic leukaemia.