Perioperative Treatment with Tranexamic Acid in Melanoma

Last updated: March 13, 2025
Sponsor: University of Aarhus
Overall Status: Active - Recruiting

Phase

3

Condition

Melanoma

Treatment

Tranexamic acid

Saline

Clinical Study ID

NCT05899465
PRIME
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 orBreslow 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

Exclusion Criteria:

Patients

  • With a prior history of invasive melanoma

  • Thromboembolic events within the last 3 months

  • Pregnancy

  • Active breastfeeding

  • Known allergy or hypersensitivity to TXA

  • Known and treated epilepsia or previous seizures

  • eGFR 0-50

  • Current use of tranexamic acid

Study Design

Total Participants: 1204
Treatment Group(s): 2
Primary Treatment: Tranexamic acid
Phase: 3
Study Start date:
August 25, 2023
Estimated Completion Date:
September 01, 2028

Study Description

The objective of the proposed clinical trial is to test if perioperative treatment with tranexamic acid (TXA) reduces the early relapses and postoperative complications for patients with melanoma and evaluate perioperative inflammation and the prognostic- and treatment-related impact of the plasminogen-plasmin pathway from human blood- and tissue samples.

Primary aim:

To test if perioperative treatment with TXA is superior to placebo and reduces the early relapse rates, from 37% to 26%, for patients diagnosed with melanoma undergoing sentinel lymph node biopsy surgery.

Secondary aims:

  1. Evaluate safety and tolerability: defined as mild (abdominal pain, diarrhea, or nausea) or severe (thromboembolic events) adverse effects.

  2. Evaluate postoperative complications: defined as bleeding, seroma formation, and infections within the first three postoperative months.

  3. Estimate melanoma-specific survival probabilities and compare the two treatment groups.

Explorative:

From blood- and tissue samples, baseline and perioperative changes of factors associated with inflammation, fibrinolysis, metabolism, immune cell composition, and activation status will be monitored and factors will be associated with prognostic and treatment-related outcomes.

Connect with a study center

  • Aarhus University Hospital

    Aarhus, Central Denmark Region
    Denmark

    Active - Recruiting

  • Aarhus University Hospital. Dept. of Plastic- and Breast Surgery

    Aarhus, Central Denmark Region
    Denmark

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg, North Denmark Region
    Denmark

    Active - Recruiting

  • Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.

    Aalborg, North Denmark Region
    Denmark

    Active - Recruiting

  • Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment

    Copenhagen,
    Denmark

    Active - Recruiting

  • Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery

    Herlev,
    Denmark

    Site Not Available

  • Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery

    Vejle,
    Denmark

    Site Not Available

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