Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO)
ConditionFrostbite
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Standard of care plus Epoprostenol infusion for 8 hours (hrs) per day up to 5 days maximum
- Standard of Care + Placebo (Normal Saline)infusion for 8 hours per day up to 5 days maximum
Treatment groups
66 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Colorado, Denver
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov