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RECRUITING
NCT05899465
PHASE3

Perioperative Treatment With Tranexamic Acid in Melanoma

Sponsor: University of Aarhus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1204

Start Date

2023-08-25

Completion Date

2028-09-01

Last Updated

2025-03-18

Healthy Volunteers

No

Conditions

Interventions

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

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