Postoperative HemorrhagePhase 4NCT02627560
The Effect of Topical Tranexamic Acid on Bleeding and Seroma Formation in After Undergoing Mastectomy
A Phase 4 study testing Tranexamic Acid and saline in people with Postoperative Hemorrhage and Breast Neoplasms, run by St. Olavs Hospital at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Hemorrhage, Breast Neoplasms, Seroma
- What is being tested?
- Tranexamic Acid and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2016to 1 Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Surgery, Aalesund Hospital
Ålesund
St Olavs University Hospital
Trondheim, 7006
About this study
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
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.
- Conditions
- Postoperative Hemorrhage, Breast Neoplasms, Seroma
- Being tested
- Tranexamic Acid, saline
- Keywords
- Administration, topical, Tranexamic acid, Postoperative care, Mastectomy
- Medical subject headings
- Postoperative Hemorrhage, Breast Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
salineDrug
moisten the surgical wound surface with 20 ml placebo (0.9% saline)
| Study group | Role | What they receive |
|---|---|---|
| topical tranexamic acid | Experimental | tranexamic acid to be smeared on surgical wounds before closure Receives: Drug: Tranexamic Acid |
| placebo control | Placebo comparator | saline to be smeared on surgical wounds before closure Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours postoperatively
Secondary outcomes (4)
Daily drain production up to drain removal - cumulative volume
Measured: 3 weeks
number of patients having surgical bleeding in need of re-operation
Measured: 3 weeks
number of postoperative aspirations of clinical seroma
Measured: up to 3 months
chronic seroma (lasting more than three months)
volume of seroma aspirated
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Petter Aadahl, MD PhD, Study director, St. Olavs HospitalSverrir Olafsson, Study director, Ålesund Sykehus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627560
- Sponsor's protocol ID
- 2015/1722
- Other IDs
- 2015-003160-37, 2015
- Status last verified
- Nov 2018
- First submitted
- 2 Dec 2015
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26349843Ausen 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.
PubMed 32207575
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02627560
- Acronym / sponsor ID
- 2015/1722
- Conditions
- Postoperative Hemorrhage, Breast Neoplasms, Seroma
- Keywords
- Administration, topical, Tranexamic acid, Postoperative care, Mastectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Alesund Hospital
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical tranexamic acid | Experimental | Drug: Tranexamic Acidtranexamic acid to be smeared on surgical wounds before closure |
| placebo control | Placebo comparator | Drug: salinesaline to be smeared on surgical wounds before closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acidmoisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml | Drug | topical tranexamic acid |
| salinemoisten the surgical wound surface with 20 ml placebo (0.9% saline) | Drug | placebo control |
Primary outcome
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
4 secondary outcomes
Daily drain production up to drain removal - cumulative volume
Time frame: 3 weeks
number of patients having surgical bleeding in need of re-operation
Time frame: 3 weeks
number of postoperative aspirations of clinical seroma
Time frame: up to 3 months
chronic seroma (lasting more than three months)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Background: PubMed 26349843Ausen 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 publication: PubMed 32207575Ausen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Aadahl, MD PhD study director
St. Olavs Hospital
Sverrir Olafsson study director
Ålesund Sykehus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and saline in people with Postoperative Hemorrhage and Breast Neoplasms, run by St. Olavs Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bleeding as defined by drain production per hour the first 24 hours (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627560, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.