Using Tranexamic Acid to Prevent Relapses in Melanoma Patients After Surgery
Official title: Perioperative Treatment With Tranexamic Acid in Melanoma; Prognostic and Treatment-related Impact of the Plasminogen-plasmin Pathway
Run by University of Aarhus · NCT05899465 · Data updated 2026-11-12
This study is testing if giving tranexamic acid to melanoma patients after surgery can help prevent relapses and complications compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1204 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aarhus, Central Jutland and 4 other locations) |
| Status | Recruiting |
| Started | August 25, 2023 |
| Main results expected | September 1, 2026 |
| Study ends | September 1, 2028 |
| Registry record updated | March 18, 2025 |
| Trial ID | NCT05899465 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 80 diagnosed with invasive cutaneous melanoma eligible for surgery.
✕Probably not a fit
Patients with a prior history of invasive melanoma, recent thromboembolic events, or those currently using tranexamic acid may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of perioperative treatment with tranexamic acid (TXA) in reducing early relapse rates and postoperative complications in patients diagnosed with melanoma undergoing surgery. The study will compare the outcomes of patients receiving TXA to those receiving a placebo, focusing on relapse rates, safety, and postoperative complications. Additionally, the trial will explore changes in inflammation and immune response through blood and tissue samples to understand the treatment's impact on patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce early relapse rates in melanoma patients, improving their long-term survival and quality of life.
How similar studies have gone: While the use of tranexamic acid in cancer treatment is gaining interest, this specific approach in melanoma is novel and has not been extensively tested in prior studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Aarhus University Hospital. Dept. of Plastic- and Breast Surgery
Aarhus, Central Jutland, Denmark Recruiting -
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.
Aalborg, North Denmark, Denmark Recruiting -
Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment
Copenhagen, Denmark Recruiting -
Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery
Herlev, Denmark Active not recruiting -
Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery
Vejle, Denmark Active not recruiting
Study contacts
- Study coordinator: Marie Louise Bønnelykke-Behrndtz, MD, PhD
- Email: marboe@rm.dk
- Phone: +45 78 45 00 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.