Tranexamic Acid for Alloplastic Breast Reconstruction

April 4, 2022 updated by: McMaster University

Effects of Tranexamic Acid for Alloplastic Breast Reconstruction: A Randomized Control Trial

Hematoma is a common complication of alloplastic breast reconstruction. 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) assessing TXA use in alloplastic breast reconstruction, 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 alloplastic breast reconstruction 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 alloplastic breast reconstruction. 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 reconstruction. 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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8G 5E4
        • St. Joseph's Healthcare, King Campus
        • Contact:
          • Mark McRae, MD, FRCSC
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare, Charlton Campus
        • Contact:
          • Sophoceles Voineskos, MD, FRCSC
      • Hamilton, Ontario, Canada, L8V 1C3
        • Juravinski Hospital, Hamilton Health Sciences
        • Contact:
          • Ronen Avram, MD, FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Are 18 years or older;
  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
40 mL topical of 0.9% normal saline
Drug: Normal Saline
40 mL topical of 0.9% normal saline
Other Names:
  • NS
Experimental: Tranexamic Acid
3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
Drug: Tranexamic acid
3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
Other Names:
  • TXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma
Time Frame: 2 weeks
Incidence rate of hematoma
2 weeks
Seroma
Time Frame: 2 weeks
Incidence rate of seroma
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drain output
Time Frame: 24 hours
Total drain output (mL) at 24 hours
24 hours
Days with drains
Time Frame: 2 weeks
Total number of days drains in situ with standard discharge criteria
2 weeks
Reoperation rate
Time Frame: 2 weeks
Number of repeat operations required for patient related to complication
2 weeks
Reintervention rate
Time Frame: 2 weeks
Rate of subsequent interventions including aspiration, repeat drain insertion or other
2 weeks
Imaging findings
Time Frame: 2 weeks
Ultrasound findings of hematoma or seroma, if applicable
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Ronen Avram, MD, FRCSC, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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