NCT05899465RecruitingPhase 3
Perioperative Treatment With Tranexamic Acid in Melanoma
Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Surgery is a key element in the treatment of melanoma, and naturally linked with an inflammatory response and recruitment of innate immune cells. Although surgery has a favorable intent, surgery-induced inflammation, neutrophils in particular, may accelerate growth of local and systemic micrometastases. Thus, improving cancer surgery and modulating the wound microenvironment in ways that benefit the patients is crucial. Repurposing already approved drugs in a cancer setting has gained increasing interest in recent years. Interestingly, tranexamic acid was recently suggested as an anti-cancer drug, capable of reducing tumor growth in experimental animal models and reducing the viability of different melanoma cell lines. As a novel approach, sponsor and investigators will conduct a Randomised Clinical Trial, using perioperative treatment with Tranexamic Acid, aiming to prevent the early relapses for patients with melanoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1204 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- University of Aarhus
- Diseases
- Melanoma
- NCT number
- NCT05899465
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1204
- From 25 Aug 2023 to the primary completion date, 1 Sept 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known and treated epilepsia or previous seizures
Other illness
- With a prior history of invasive melanoma
- Known allergy or hypersensitivity to TXA
Lab values
- eGFR 0-50
Other
- Patients
- Thromboembolic events within the last 3 months
- Pregnancy
- Active breastfeeding
- Current use of tranexamic acid
Who the study is looking for
- Patients
- Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade ≥T2b), defined as either: Breslow thickness \>1.0-2.0 mm with presence of ulceration or Breslow thickness \>2.0 mm regardless of ulceration status.
- Eligible for surgery (wide local excision and sentinel lymph node biopsy).
- \>/=18 years of age and \</=80 years of age
- Signed Informed Consent Form
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital. Dept. of Plastic- and Breast Surgery. Coordinator of this site? Confirm its status | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital. Dept. of Plastic- and Breast Surgery Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
| Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery Coordinator of this site? Confirm its status | Herlev | Denmark | Active, not recruiting |
| Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery Coordinator of this site? Confirm its status | Vejle | Denmark | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.