NCT02627560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
202

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 12, 2020

Status Verified

November 1, 2018

Enrollment Period

2.8 years

First QC Date

December 2, 2015

Last Update Submit

May 8, 2020

Conditions

Postoperative HemorrhageBreast NeoplasmsSeroma

Keywords

Administration, topicalTranexamic acidPostoperative careMastectomy

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hours postoperatively

Secondary Outcomes (4)

  • Daily drain production up to drain removal - cumulative volume

    3 weeks

  • number of patients having surgical bleeding in need of re-operation

    3 weeks

  • number of postoperative aspirations of clinical seroma

    up to 3 months

  • chronic seroma (lasting more than three months)

    3 months

Study Arms (2)

topical tranexamic acid

EXPERIMENTAL

tranexamic acid to be smeared on surgical wounds before closure

Drug: Tranexamic Acid

placebo control

PLACEBO COMPARATOR

saline to be smeared on surgical wounds before closure

Drug: saline

Interventions

Tranexamic AcidDRUG

moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml

topical tranexamic acid
salineDRUG

moisten the surgical wound surface with 20 ml placebo (0.9% saline)

placebo control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Aalesund Hospital

Ålesund, Norway

Location

St Olavs University Hospital

Trondheim, 7006, Norway

Location

Related Publications (2)

  • 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.

    PMID: 26349843BACKGROUND

  • 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.

    PMID: 32207575RESULT

MeSH Terms

Conditions

Postoperative HemorrhageBreast NeoplasmsSeroma

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesInflammation

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Petter Aadahl, MD PhD

    St. Olavs Hospital

    STUDY DIRECTOR

  • Sverrir Olafsson

    Ålesund Sykehus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 11, 2015

Study Start

January 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

May 12, 2020

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)