Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO) (NCT07424378) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO)
United States66 participantsStarted 2026-02
Plain-language summary
Severe frostbite injury can result in significant lifelong disability and amputation. Various medicines, including intravenous vasodilators (prostaglandins/iloprost, pentoxifylline, buflomedil) along with thrombolytics (alteplase), have been described to counter tissue ischemia after rewarming, with poor quality of evidence. An in-class prostacyclin, epoprostenol, has similar pharmacodynamic properties to iloprost including vasodilation and platelet inhibition and has been used in peripheral tissue ischemia such as Raynaud's and scleroderma. In this trial, we will evaluate the effectiveness and safety of epoprostenol treatment for severe frostbite injury in addition to standard of care.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged ≥ 18 years
✓. Admitted to University of Colorado Hospital (UCH) Burn and Frostbite Center
✓. Cauchy Grade 2-4 frostbite injury
✓. Admission within 72 hours post-rewarming
Exclusion criteria
✕. Patients unable to initiate therapy within 72 hours post-rewarming
✕. Unsalvageable frostbite as defined by obvious necrosis of tissue, wet gangrene, or other condition requiring amputation (within the first week)
✕. Anticipated death within 48 hours of admission
✕. Pregnant or breastfeeding patients
✕. Prisoners
✕. Inability to obtain consent from patient or legally authorized representative (LAR) or proxy
✕
What they're measuring
1
Amputation Rate
Timeframe: from enrollment to the end of treatment when client returns for clinic visit at 90 days.