Tests tranexamic acid around surgery in people with melanoma
Tests tranexamic acid during surgery in adults with melanoma skin cancer.
Plain-language title generated from the registry record
Registry title: Perioperative Treatment With Tranexamic Acid in Melanoma
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Herlev, and Vejle, DenmarkSee the 5 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05899465, who can take part
Where in Denmark
- Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.Aalborg, DenmarkTaking people
- Aarhus University Hospital. Dept. of Plastic- and Breast SurgeryAarhus, DenmarkTaking people
- Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns TreatmentCopenhagen, DenmarkTaking people
- Copenhagen University Hospital, Herlev. Dept. of Plastic SurgeryHerlev, DenmarkNo longer taking part
- Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic SurgeryVejle, DenmarkNo longer taking part
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?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05899465
- Record updated
- 18 March 2025
- Original description
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.Read full original descriptionShow less
Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway
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.
Inclusion: 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.
Exclusion: Known and treated epilepsia or previous seizures; With a prior history of invasive melanoma; Known allergy or hypersensitivity to TXA; eGFR 0-50; Patients; Thromboembolic events within the last 3 months; Pregnancy; Active breastfeeding; Current use of tranexamic acid.