RecruitingPhase 3NCT05899465

Perioperative Treatment With Tranexamic Acid in Melanoma

Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway


Sponsor

University of Aarhus

Enrollment

1,204 participants

Start Date

Aug 25, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria9

  • 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

Interventions

DRUGTranexamic acid

A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4

DRUGSaline

A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4


Locations(5)

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

Aarhus, Central Jutland, Denmark

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

Aalborg, North Denmark, Denmark

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

Copenhagen, Denmark

Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery

Herlev, Denmark

Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery

Vejle, Denmark

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NCT05899465


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