Finding studies
Finding studies
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Marie Louise Bønnelykke-Behrndtz, MD, PhD
CONTACT
Karoline Kristjansen, MD
CONTACT
Lead
University of Aarhus
With
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.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
