Does peri-operative treatment with Tranexamic Acid reduce the early relapse rate for patients with melanoma; a randomised controlled trial
Phase 1
Recruiting
- Conditions
- MelanomaSurgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502633-26-00
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1204
Inclusion Criteria
Patients: Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade higher than 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 prior history of invasive melanoma Thromboembolic events within the last 3 months Pregnancy * Active breast feeding Known allergy or hypersensitivity to TXA Known and treated epilepsia or previous seizures eGFR 0-50
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method