Taking people in DenmarkPhase 3
Tests tranexamic acid around surgery in people with melanoma
Tests tranexamic acid against placebo in adults with melanoma having lymph node surgery.
Key facts
- Who runs it
- Aarhus University Hospital
- Where
- Aalborg, Aarhus N, Copenhagen Oe, Herlev, Odense C, Roskilde, and Vejle, DenmarkSee the 7 sites
- Trial code
- Registry title
- Does peri-operative treatment with Tranexamic Acid reduce the early relapse rate for patients with melanoma; a randomised controlled trial
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 638 people, planned
- Started
- 25 Aug 2023
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional
- Record updated
- 28 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 80 with thicker invasive skin melanoma who will have surgery to remove the tumour and a nearby lymph node biopsy.
- Age
- 18 to 80 years
- Sex
- All sexes
- Disease stage
- Invasive melanoma of the skin: Breslow thickness above 1.0 to 2.0 mm with ulceration, or Breslow thickness above 2.0 mm with or without ulceration (higher than T2b).
- Earlier treatment
- No earlier invasive melanoma. Must be able to have wide local excision and sentinel lymph node biopsy.
Main reasons for not taking part
- Earlier invasive melanoma
- Blood clot event (thromboembolism) in the last 3 months
- Pregnancy or active breastfeeding
- Known allergy or hypersensitivity to TXA
- Known and treated epilepsy or earlier seizures
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkTaking people
- Aarhus University HospitalAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Zealand University HospitalRoskilde, DenmarkTaking people
- Lillebaelt HospitalVejle, DenmarkTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Perioperative treatment with Tranexamic Acid (TXA) in melanoma; prognostic and treatment related impact of the plasminogen-plasmin pathway
- Plain-language title
- Tests tranexamic acid around surgery in people with melanomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 July 2026