Topical Tranexamic Acid for Bilateral Breast Reduction Surgery

NCT ID: NCT04918576

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2024-08-31

Brief Summary

Hematoma is a common complication of bilateral breast reduction (BBR) surgery. This can lead to pain and discomfort experienced by the patient, in addition to greater use of valuable healthcare resources. Previous studies have shown correlation between the use of tranexamic acid (TXA), an anti-fibrinolytic, and reduced post-surgical bleeding complication events.

In this randomized control trial (RCT) evaluation TXA use in BBR, for which one breast will be randomized to have TXA applied topically, while the other will have normal saline (NS) placebo applied. The primary objective of this prospective blinded randomized control trial study is to determine if the administration of topical TXA in BBR reduces the incidence of surgical site hematoma compared to placebo within 2 weeks following surgery. The results of this study will be used to inform the design of a larger multicentered RCT on TXA in breast surgery.

Detailed Description

The primary objective of this study is to investigate the use of topical application of tranexamic Acid (TXA) to the surgical wound as a means to decrease hematoma formation compared to placebo in patients undergoing bilateral breast reduction (BBR). This project is designed as a single-center RCT to evaluate the effectiveness of topical TXA in this patient population.

If enrolled in this study, patients individual breasts will be randomly assigned to one of two treatment groups for to apply to the wound before it is closed. One breast will have an intravenous form of TXA applied topically to the surgical site. The other will be have a topical normal saline solution applied to the wound before closure (a placebo).

The patients will have the standard number of drains and postoperative instructions for breast reduction. They will follow-up at two weeks time in clinic for assessment, and emergency room visits will be also be evaluated. Standard of care will be practiced with respect to all procedures and visits.

Conditions

Hematoma Postoperative; Tranexamic Acid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

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

Normal Saline

40 mL topical of 0.9% normal saline

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

40 mL topical of 0.9% normal saline

Interventions

Tranexamic acid

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

Intervention Type: DRUG

Normal Saline

40 mL topical of 0.9% normal saline

Intervention Type: DRUG

Other Intervention Names

TXA; NS

Eligibility Criteria

Inclusion Criteria

• Are 18 years or older;
• Are undergoing bilateral breast reduction at either Hamilton Health Sciences or St. Joseph's Hospital Hamilton.

Exclusion Criteria

• Taking therapeutic anticoagulation;
• Taking antiplatelet drugs;
• Pregnant or breast feeding;
• Allergic to TXA;
• Cannot provide informed consent;
• Have a documented coagulopathy or bleeding disorder, acquired disturbances of colour vision, subarachnoid hemorrhage, hematuria, irregular menstrual bleeding, or seizure disorder.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Coroneos, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare, King Campus

Hamilton, Ontario, Canada

St. Joseph's Healthcare, Charlton Campus

Hamilton, Ontario, Canada

Juravinski Hospital, Hamilton Health Sciences

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Yaeesh Sardiwalla, MD

Role: CONTACT

yaeesh.sardiwalla@medportal.ca

90505221155

Facility Contacts

Mark McRae, MD, FRCSC

Role: primary

Sophoceles Voineskos, MD, FRCSC

Role: primary

Christopher Coroneos, MD, FRCSC

Role: primary

References

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Other Identifiers

13103

Identifier Type: -

Identifier Source: org_study_id