The Effect of Local Application of Tranexamic Acid Versus Placebo on Postoperative Complications in Plastic Surgery
NCT ID: NCT06270407
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
3000 participants
INTERVENTIONAL
2024-10-01
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a study to investigate whether applying the drug tranexamic acid (TXA) onto a surgical wound surface may affect the incidence of surgical complications such as re-bleeding needing intervention, wound complications such as infection, wound rupture or seroma, or if it may increase the risk of blood clots.
Eligible patients:
Patients undergoing plastic surgical procedures with wounds that would normally receive application of TXA to reduce bleeding after surgery.
Study intervention:
Participants will receive a single local application of study drug onto their wound surfaces at the end of surgery. Study drug will be identical looking ampoules which contain either TXA or placebo (saline). Neither participants nor study personnel will know the contents of the ampoules.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Screening of patient medical records
* Distribution of an electronic self-report form (eForsk®) to participating patients at postoperative day 30
* Follow-up phone call to verify data after day 30.
The study is terminated after the final phone call. All study data will be registered in an electronic, pseudonymous web-based registration form (eCRF/Viedoc®).
Number of participants: To assess the effect of TXA on the defined surgical complications compared to placebo, 1500 patients are needed in each group.
Data monitoring committee:
A data monitoring committee consisting of a group of independent scientists will be appointed for this study to monitor the safety and scientific integrity of this human research intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Randomization, blinding, labelling, shipment of ampoules and keeping of the randomization code will be done by Smerud Medical Research International AS.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tranexamic acid arm
Anonymous ampoule containing 5 ml of 100 mg/ml Tranexamic Acid. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.
Tranexamic Acid 100 MG/ML
If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid
Placebo arm
Anonymous ampoule containing 5 ml of 0.9% NaCl. If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.
0.9%sodium chloride
If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tranexamic Acid 100 MG/ML
If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using tranexamic acid
0.9%sodium chloride
If surgeon wants to apply tranexamic acid onto the wound surface, the study ampoule will be diluted and applied in accordance with the surgeon's practice when using Tranexamic Acid.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. They are to undergo a surgical procedure within the field of plastic surgery where the procedure involves use of topical TXA at the participating center.
2. They are over 18 years of age and capable of independently providing informed consent
3. They have received adequate oral and written information about the study and signed the informed-consent form
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Smerud Medical Research International AS
OTHER
Sykehuset Asker og Baerum
OTHER
Oslo University Hospital
OTHER
Sykehuset Telemark
OTHER_GOV
Sykehuset Innlandet HF
OTHER
Molde Hospital
OTHER
Haukeland University Hospital
OTHER
Haraldsplass Deaconess Hospital
OTHER
Helse Stavanger HF
OTHER_GOV
University Hospital of North Norway
OTHER
Bodø sykehus
UNKNOWN
Helsinki University Central Hospital
OTHER
St. Olavs Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kjersti Ausen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
St Olav's University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Olav's University Hospital
Trondheim, , Norway
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-001580-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-510381-28-01
Identifier Type: REGISTRY
Identifier Source: secondary_id
270777
Identifier Type: -
Identifier Source: org_study_id