2022-502633-26-00RecruitingPhase 3
Does peri-operative treatment with Tranexamic Acid reduce the early relapse rate for patients with melanoma; a randomised controlled trial
Perioperative treatment with Tranexamic Acid (TXA) in melanoma; prognostic and treatment related impact of the plasminogen-plasmin pathway
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Jul 2026
Brief summary (registry, in English)
To test if perioperative treatment with TXA is superior to placebo and reduces the early relapse rates by >10%, for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 638 (estimated)
- First submitted
- 30 Nov 2022
- Start date
- 25 Aug 2023
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Melanoma
- EU CT number
- 2022-502633-26-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 638
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Lab values
- Patients: With prior history of invasive melanoma Thromboembolic events within the last 3 months Pregnancy * Active breast feeding Known allergy or hypersensitivity to TXA Known and treated epilepsia or previous seizures eGFR 0-50
Who the study is looking for
- Patients: Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade higher than 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 - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital | Aarhus N | Denmark | Recruiting |
| Rigshospitalet | Copenhagen Oe | Denmark | Recruiting |
| Herlev Hospital | Herlev | Denmark | Recruiting |
| Odense University Hospital | Odense C | Denmark | Recruiting |
| Zealand University Hospital | Roskilde | Denmark | Recruiting |
| Lillebaelt Hospital | Vejle | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.