RecruitingPhase 3NCT05899465

Perioperative Treatment With Tranexamic Acid in Melanoma

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


Sponsor

University of Aarhus

Enrollment

1,204 participants

Start Date

Aug 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing tranexamic acid — a medication that reduces bleeding — given around the time of surgery to see if it can lower the risk of melanoma spreading. Some research suggests that limiting blood loss during surgery may reduce cancer spread. **You may be eligible if...** - You have been diagnosed with invasive melanoma (thicker than 1mm with ulceration, or thicker than 2mm) - You are eligible for surgery (wide local excision and sentinel lymph node biopsy) - You are between 18 and 80 years old **You may NOT be eligible if...** - You have had a prior invasive melanoma - You had a blood clot (deep vein thrombosis or pulmonary embolism) in the last 3 months - You are pregnant or breastfeeding - You have a known allergy to tranexamic acid - You have epilepsy or a history of seizures - Your kidney function is significantly impaired (eGFR 0–50) - You are already using tranexamic acid Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTranexamic acid

A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4

DRUGSaline

A single preoperative intravenous dose and per os treatment postoperatively day 1 through 4


Locations(5)

Aarhus University Hospital. Dept. of Plastic- and Breast Surgery

Aarhus, Central Jutland, Denmark

Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.

Aalborg, North Denmark, 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 Lillebælt, Vejle Hospital. Dept. of Plastic Surgery

Vejle, Denmark

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NCT05899465


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