BridgeMD
New treatment option for Melanoma
Official title Perioperative Treatment With Tranexamic Acid in Melanoma
ClinicalTrials.gov ID: NCT05899465
What this study is testing
What is Tranexamic acid?
Tranexamic acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients
- Diagnosed with invasive cutaneous melanoma (pathological stage/tumor grade ≥T2b), defined as either: Breslow thickness \>1.0-2.0 mm with presence of...
- Eligible for surgery (wide local excision and sentinel lymph node biopsy).
- \>/=18 years of age and \</=80 years of age
- Signed Informed Consent Form
You likely can't join if
- Patients
- With a prior history of invasive melanoma
- Thromboembolic events within the last 3 months
- Pregnancy
- Active breastfeeding
- Known allergy or hypersensitivity to TXA
See the full eligibility 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...
- Eligible for surgery (wide local excision and sentinel lymph node biopsy).
- \>/=18 years of age and \</=80 years of age
- Signed Informed Consent Form
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Central Jutland, Denmark
- Aalborg, North Denmark, Denmark
- Copenhagen, Denmark
- Herlev, Denmark
- Vejle, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Central Jutland, Denmark; Aalborg, North Denmark, Denmark; Copenhagen, Denmark; Herlev, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.