Clinical Trial

Perioperative Treatment With Tranexamic Acid in Melanoma

Study acronym: PRIME
Recruiting Phase 3
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-06-02; most recent amendment 2025-03-13.
Status change: Not Yet Recruiting → Recruiting 2023-11-08
Trial Details
NCT Number NCT05899465
Lead Sponsor University of Aarhus
Collaborators: Aarhus University Hospital, Central Denmark Region
Conditions Melanoma
Enrollment 1,204 participants
Start Date 2023-08-25
Primary Completion 2026-09-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-18