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Perioperative Treatment With Tranexamic Acid in Melanoma

Study acronym: PRIME
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 18, 2025 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Study sites: 2 to 5v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary completion date: Apr 2028 to Sep 1, 2026
    • Study sites: 0 to 2
    • Study completion date: Apr 2029 to Sep 1, 2028
    • Start date changed from estimate of Aug 2023 to Aug 25, 2023
    • Secondary endpoints: 6 to 5
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,092 trials monitored
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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.
Trial Details
NCT Number NCT05899465
Lead Sponsor University of Aarhus
Collaborators: Aarhus University Hospital, Central Denmark Region
Conditions
(from sponsor)
Melanoma
Related terms Melanoma, Neoplasms, Recurrence
Enrollment 1,204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov