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Perioperative Treatment With Tranexamic Acid in Melanoma

NCT05899465 · University of Aarhus
In plain English

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Official title
Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway
About this study
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.
Eligibility criteria
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 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
Study design
Enrollment target: 1204 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-08-25
Estimated completion: 2028-09-01
Last updated: 2025-03-18
Interventions
Drug: Tranexamic acidDrug: Saline
Primary outcomes
  • Difference in rate of relapse within two years when comparing treatment arms (2 year follow-up)
Sponsor
University of Aarhus · other
With: Aarhus University Hospital, Central Denmark Region
Contacts & investigators
ContactMarie Louise Bønnelykke-Behrndtz, MD, PhD · contact · marboe@rm.dk · +45 78 45 00 00
ContactKaroline Kristjansen, MD · contact · karoline_kristjansen@clin.au.dk
All locations (5)
Aarhus University Hospital. Dept. of Plastic- and Breast SurgeryRecruiting
Aarhus, Central Jutland, Denmark
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.Recruiting
Aalborg, North Denmark, Denmark
Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns TreatmentRecruiting
Copenhagen, Denmark
Copenhagen University Hospital, Herlev. Dept. of Plastic SurgeryActive Not Recruiting
Herlev, Denmark
Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic SurgeryActive Not Recruiting
Vejle, Denmark
Perioperative Treatment With Tranexamic Acid in Melanoma · TrialPath