NCT05899465

Perioperative Treatment With Tranexamic Acid in Melanoma

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,204 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Tranexamic acid	A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4
DRUG	Saline	A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4

Timeline

• Start date: 2023-08-25
• Primary completion: 2026-09-01
• Completion: 2028-09-01
• First posted: 2023-06-12
• Last updated: 2025-03-18

Locations

5 sites across 1 country: Denmark