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

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ClinicalTrials.gov Identifier: NCT02627560
Recruitment Status : Completed
First Posted : December 11, 2015
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Alesund Hospital
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Postoperative Hemorrhage Breast Neoplasms Seroma Drug: Tranexamic Acid Drug: saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Mastectomy

Arm Intervention/treatment
Experimental: topical tranexamic acid
tranexamic acid to be smeared on surgical wounds before closure
Drug: Tranexamic Acid
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
Drug: saline
moisten the surgical wound surface with 20 ml placebo (0.9% saline)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Daily drain production up to drain removal - cumulative volume [ Time Frame: 3 weeks ]
  2. number of patients having surgical bleeding in need of re-operation [ Time Frame: 3 weeks ]
  3. number of postoperative aspirations of clinical seroma [ Time Frame: up to 3 months ]
  4. chronic seroma (lasting more than three months) [ Time Frame: 3 months ]
    volume of seroma aspirated



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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®

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02627560


Locations
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Norway
St Olavs University Hospital
Trondheim, Norway, 7006
Department of Surgery, Aalesund Hospital
Ålesund, Norway
Sponsors and Collaborators
St. Olavs Hospital
Alesund Hospital
Investigators
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Study Director: Petter Aadahl, MD PhD St. Olavs Hospital
Study Director: Sverrir Olafsson Ålesund Sykehus

Publications:
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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02627560     History of Changes
Other Study ID Numbers: 2015/1722
2015-003160-37 ( EudraCT Number )
First Posted: December 11, 2015    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Olavs Hospital:
Administration, topical
Tranexamic acid
Postoperative care
Mastectomy
Additional relevant MeSH terms:
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Tranexamic Acid
Breast Neoplasms
Hemorrhage
Seroma
Postoperative Hemorrhage
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Inflammation
Postoperative Complications
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants