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

Primary Purpose

Postoperative Hemorrhage, Breast Neoplasms, Seroma

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Tranexamic Acid
saline
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hemorrhage focused on measuring Administration, topical, Tranexamic acid, Postoperative care, Mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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®

Sites / Locations

  • St Olavs University Hospital
  • Department of Surgery, Aalesund Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

topical tranexamic acid

placebo control

Arm Description

tranexamic acid to be smeared on surgical wounds before closure

saline to be smeared on surgical wounds before closure

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 2, 2015
Last Updated
May 8, 2020
Sponsor
St. Olavs Hospital
Collaborators
Alesund Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02627560
Brief Title
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Alesund Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hemorrhage, Breast Neoplasms, Seroma
Keywords
Administration, topical, Tranexamic acid, Postoperative care, Mastectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical tranexamic acid
Arm Type
Experimental
Arm Description
tranexamic acid to be smeared on surgical wounds before closure
Arm Title
placebo control
Arm Type
Placebo Comparator
Arm Description
saline to be smeared on surgical wounds before closure
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
moisten the surgical wound surface with 20 ml placebo (0.9% saline)
Primary Outcome Measure Information:
Title
bleeding as defined by drain production per hour the first 24 hours
Description
Drains are placed in surgical wounds during operation, and amount of blood on drains measured in ml
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Daily drain production up to drain removal - cumulative volume
Time Frame
3 weeks
Title
number of patients having surgical bleeding in need of re-operation
Time Frame
3 weeks
Title
number of postoperative aspirations of clinical seroma
Time Frame
up to 3 months
Title
chronic seroma (lasting more than three months)
Description
volume of seroma aspirated
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petter Aadahl, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sverrir Olafsson
Organizational Affiliation
Ålesund Sykehus
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Department of Surgery, Aalesund Hospital
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26349843
Citation
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.
Results Reference
background
PubMed Identifier
32207575
Citation
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.
Results Reference
result

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

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