- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627560
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Trondheim, Norway, 7006
- St Olavs University Hospital
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Ålesund, Norway
- Department of Surgery, Aalesund Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
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Placebo Comparator: placebo control
saline to be smeared on surgical wounds before closure
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moisten the surgical wound surface with 20 ml placebo (0.9% saline)
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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
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Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
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24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily drain production up to drain removal - cumulative volume
Time Frame: 3 weeks
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3 weeks
|
|
number of patients having surgical bleeding in need of re-operation
Time Frame: 3 weeks
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3 weeks
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number of postoperative aspirations of clinical seroma
Time Frame: up to 3 months
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up to 3 months
|
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chronic seroma (lasting more than three months)
Time Frame: 3 months
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volume of seroma aspirated
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3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Sverrir Olafsson, Ålesund sykehus
Publications and helpful links
General Publications
- Ausen K, Fossmark R, Spigset O, Pleym H. Randomized clinical trial of topical tranexamic acid after reduction mammoplasty. Br J Surg. 2015 Oct;102(11):1348-53. doi: 10.1002/bjs.9878.
- Ausen K, Hagen AI, Ostbyhaug HS, Olafsson S, Kvalsund BJ, Spigset O, Pleym H. Topical moistening of mastectomy wounds with diluted tranexamic acid to reduce bleeding: randomized clinical trial. BJS Open. 2020 Apr;4(2):216-224. doi: 10.1002/bjs5.50248. Epub 2019 Dec 26.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Inflammation
- Postoperative Complications
- Breast Diseases
- Breast Neoplasms
- Hemorrhage
- Postoperative Hemorrhage
- Seroma
- Molecular Mechanisms of Pharmacological Action
- Fibrin Modulating Agents
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Tranexamic Acid
Other Study ID Numbers
- 2015/1722
- 2015-003160-37 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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