The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy

May 8, 2020 updated by: St. Olavs Hospital

The Effect of Topical Administration of Tranexamic Acid on Postoperative Bleeding and Seroma Formation in Patients Undergoing Mastectomy: A Prospective Placebo-controlled Double Blinded Randomized Study

After surgical procedures, interventions to reduce postoperative bleeding are of great importance. In this study, the effect will be investigated of smearing tranexamic acid, which is designed for injection, directly onto the raw wound surface (topical application) created during surgery. Topical application allows a small amount of drug to reach a large wound area, higher drug concentration in the exposed wound surface but very low concentration in the body, and no risk of injury from needles. The researchers have recently shown that topically applicated tranexamic acid reduces bleeding in women who had two-sided breast reduction surgery. Now it will be studied whether topically applicated tranexamic acid reduces bleeding after breast surgery for breast cancer.

After surgery for breast cancer patients may also experience problems with long lasting seroma. Therefore it will at the same time be investigated whether topical tranexamic acid reduces the development of seroma in these patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

      • Trondheim, Norway, 7006
        • St Olavs University Hospital
      • Ålesund, Norway
        • Department of Surgery, Aalesund Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • breast cancer
  • undergoing unilateral mastectomy with or without axillary node dissection
  • received adequate oral and written information about the study and signed an informed-consent form

Exclusion Criteria:

  • pregnant or breastfeeding
  • known thromboembolic disease or with high risk of thromboembolism, warranting extra anticoagulation in connection with the procedure
  • known allergy to tranexamic acid/Cyklokapron®

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: topical tranexamic acid
tranexamic acid to be smeared on surgical wounds before closure
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
Placebo Comparator: placebo control
saline to be smeared on surgical wounds before closure
moisten the surgical wound surface with 20 ml placebo (0.9% saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bleeding as defined by drain production per hour the first 24 hours
Time Frame: 24 hours postoperatively
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily drain production up to drain removal - cumulative volume
Time Frame: 3 weeks
3 weeks
number of patients having surgical bleeding in need of re-operation
Time Frame: 3 weeks
3 weeks
number of postoperative aspirations of clinical seroma
Time Frame: up to 3 months
up to 3 months
chronic seroma (lasting more than three months)
Time Frame: 3 months
volume of seroma aspirated
3 months

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Director: Sverrir Olafsson, Ålesund sykehus

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.

Helpful Links

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 (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

November 1, 2018

More Information

Terms related to this study

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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