Clinical Research Directory
Browse clinical research sites, groups, and studies.
Field Study on Intravenous Iloprost for Treatment of Severe Frostbite at High Altitude
Sponsor: Institute of Mountain Emergency Medicine
Summary
The goal of this observational study is to learn whether intravenous iloprost treatment for severe frostbite (grades 3-4) is feasible and safe when delivered in pre-hospital, remote high-altitude settings. The main questions it aims to answer are: * Is it feasible to initiate and deliver guideline-based intravenous iloprost for grade 3-4 frostbite at high altitude and what logistical barriers arise? * Does field-based initiation of iloprost increase tissue preservation and reduce amputations (compared to historical cases from similar settings)? Participants receiving Iloprost as part of a frostbite treatment will be followed up after discharge as well as 6, 12 and 18 months to assess tissue preservation and long-term sequelae from the initial frostbite injury.
Official title: High-Altitude Iloprost Feasibility Study for Treatment of Frostbite
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
10
Start Date
2026-05
Completion Date
2028-05
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
Iloprost (Ilomedin, BAYQ6256)
Begin Iloprost intravenous infusion as soon as feasible for all Grade 2-4 frostbite cases (optimally within 24-72 hours of injury, but it can be beneficial even if started later). Iloprost is a prostacyclin analogue vasodilator that improves blood flow and inhibits platelet aggregation, thereby counteracting frostbite's ischemic and thrombotic components. Key points for Iloprost administration: * Dosage and preparation: Iloprost is supplied in ampoules of 50mcg/0.5mL. Dilute 50 mcg into a 250mL bag of D5W (5% dextrose) to create a 0.2 mcg/mL solution. Iloprost infusion should be administered via a dedicated IV line using an infusion pump. * Infusion protocol: Start iloprost infusion at 10 mL/hour (which delivers 2 mcg/hour, assuming the 0.2 mcg/mL dilution). Every 30 minutes, increase infusion rate by 10 mL/hour, as tolerated, until the maximum rate appropriate for the patient's weight is reached (40-50 kg: up to 30 mL/hour; 51-74 kg: up to 40 mL/hour; ≥75 kg: up to 50 mL/hour.
Locations (1)
Eurac Research, Institute of Mountain Emergency Medicine
Bolzano, BZ, Italy