Actively Recruiting
Perioperative Treatment With Tranexamic Acid in Melanoma
Led by University of Aarhus · Updated on 2025-03-18
1204
Participants Needed
5
Research Sites
262 weeks
Total Duration
On this page
Sponsors
U
University of Aarhus
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Perioperative Treatment With Tranexamic Acid in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with invasive cutaneous melanoma with pathological stage or tumor grade 65T2b, defined as Breslow thickness >1.0-2.0 mm with ulceration or >2.0 mm regardless of ulceration
- Eligible for surgery including wide local excision and sentinel lymph node biopsy
- Between 18 and 80 years of age
- Signed informed consent form
You will not qualify if you...
- Prior history of invasive melanoma
- Thromboembolic events within the last 3 months
- Pregnancy
- Active breastfeeding
- Known allergy or hypersensitivity to tranexamic acid
- Known and treated epilepsy or previous seizures
- Estimated glomerular filtration rate (eGFR) between 0 and 50
- Current use of tranexamic acid
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Aarhus University Hospital. Dept. of Plastic- and Breast Surgery
Aarhus, Central Jutland, Denmark
Actively Recruiting
2
Aalborg University Hospital. Dept. of Plastic- and Breast Surgery.
Aalborg, North Denmark, Denmark
Actively Recruiting
3
Copgenhagen University Hospital, Rigshospitalet. Dept. of Plastic Surgery and Burns Treatment
Copenhagen, Denmark
Actively Recruiting
4
Copenhagen University Hospital, Herlev. Dept. of Plastic Surgery
Herlev, Denmark
Active, Not Recruiting
5
Sygehus Lillebælt, Vejle Hospital. Dept. of Plastic Surgery
Vejle, Denmark
Active, Not Recruiting
Research Team
M
Marie Louise Bønnelykke-Behrndtz, MD, PhD
CONTACT
K
Karoline Kristjansen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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