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Perioperative Treatment With Tranexamic Acid in Melanoma

RecruitingPhase 3Ages 18 Years - 80 YearsAllUniversity of Aarhus
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients * Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade โ‰ฅT2b), 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 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
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What it tests

  • Tranexamic acid
  • Saline
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Where

5 sites
Aarhus University Hospital. Dept. of Plastic- and Breast Surgery
Aarhus, Denmark
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.
Aalborg, 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 Lillebรฆlt, Vejle Hospital. Dept. of Plastic Surgery
Vejle, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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