Field Study on Intravenous Iloprost for Treatment of Severe Frostbite at High Altitude

NCT07450469 | Not Yet Recruiting

• 1 other identifier: HAI-Frost
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Field Physician Care; Frostbite; Altitude

Keywords

iloprost

Outcome Measures

Primary Outcomes (11)

• Proportion of frostbite presentations with severe frostbite (Grade 3-4) at Everest ER

  Patients will be assessed using Cauchy classification. Proportion of patients presenting with grade 3 + 4 frostbite in relation to the total number of patients with frostbite presenting at Everest ER Unit/format: proportion (%)

  from enrolment to the end of treatment at 1 week

• Proportion of eligible severe frostbite patients who complete ≥1 field iloprost treatment round

  The proportion of the number of patients who successfully completed at least one round of iloprost treatment under field conditions in relation to the number of eligible patients. Denominator explicitly: eligible grade 3-4 patients (Cauchy classification) Unit/format: proportion (%)

  From enrolment to 1 week after beginning of treatment

• Time from thawing to initiation of iloprost treatment under field conditions

  Unit/format: time (hours or minutes)

  From enrolment to the end of treatment at day 1

• Proportion of iloprost-treated patients with mild adverse effects during/after ≥1 treatment round in the field setting

  Unit/format: proportion (%) Adverse effects will be graded using CTCAE (CTCAE = Common Terminology Criteria for Adverse Events) severity criteria. Proportion of mild adverse effects in the field setting will then be compared with in-hospital settings.

  From enrollment to the end of treatment at 1 week

• Proportion of iloprost-treated patients with severe adverse effects during/after ≥1 treatment round in the field

  Unit/format: proportion (%) Adverse effects will be graded using CTCAE (Common Terminology Criteria for Adverse Events) severity criteria. In a second step proportion of severe adverse events during field treatment will be compared with proportions of in-hospital treatment

  From enrolment to the end of treatment at 1 week

• Proportion of patients discontinuing field iloprost treatment (overall) and documented reasons for discontinuation

  Proportion of discontinued field treatments in relation to all initiated field treatments. Unit/format: proportion (%) + categorical reason counts

  From enrolment to end of treatment at 1 week

• Proportion of iloprost treatment discontinuations attributable to adverse effects in the field

  Unit/format: proportion (%) Number of treatments discontinued due to adverse reactions in relation to all treatments discontinued (both in the field)

  From enrolment to end of treatment at 1 week

• Qualitative description of logistical constraints and solutions from field notes and staff reports

  Notes and reports will be analysed using a thematic analysis approach to categorise logistical challenges. Reported as: themes/categories with illustrative summaries (qualitative)

  From enrolment to end of treatment at 1 week

• Frequency of logistical challenges during field iloprost implementation

  Number of logistical challenges, classified using a logistical challenge themes arising from qualitative analysis of field notes and staff reports. Possible themes expected include challenges related to equipment availability or functionality, personnel issues, environmental barriers. Reported as: counts (n) and percentages (%) (number of challenges within one respective category in relation to all registered logistical challenges)

  from enrolment to end of treatment at 1 week

• Proportion of logistical challenges resolved during the study period

  Number of logistical challenges resolved in relation to all challenges recorded within one defined logistical challenge theme. Reported as: percentage (%) The logistical challenges themes will be arising from qualitative analysis of field notes and staff reports.

  from enrolment to end of treatment at week 1

• Mean (SD) time from thawing to first iloprost administration (clinical charts/notes), stratified by logistical challenge status (none vs occurred), resolution status (resolved vs unresolved), and challenge category

  Time-to-treatment in the field will be calculated as the elapsed time between the documented thawing time and the documented start time of the first iloprost administration, as recorded in clinical charts/notes. Each case will be classified by logistical challenge status (no challenge vs challenge occurred). For cases with a challenge, resolution status will be recorded as resolved during the study period vs unresolved/persisting, and challenges will also be assigned to a logistical challenge category. Time-to-treatment will be summarized as mean (SD) within each stratum (e.g., none vs resolved vs unresolved, and by category) and compared across strata.

  From enrolment to end of treatment at 1 week

Secondary Outcomes (7)

• Baseline tissue at risk for amputation (Hennepin Frostbite Score at-risk component)

  From enrolment to 1 week after treatment initiation

• Overall digital salvage rate at 6 and 12 months (Hennepin Frostbite Score-defined digits at risk vs amputated) after treatment completion

  From enrolment to 18 months after treatment completion

• Number of participants undergoing any frostbite-related amputation by 6 months and by 12 months after end of treatment (clinical charts/operative notes & self reported)

  from enrollment to follow ups up to 18 months after discharge.

• Number of joints salvaged per participant at 6 and 12 months (Hennepin Frostbite Score-based joint tissue at risk vs amputated)

  From enrolment to 18 months after discharge

• Change from baseline in pain at follow-up (measured by Numeric Rating Scale (NRS) 0-10)

  from enrolment to 18months after treatment completion

Interventions

Iloprost (Ilomedin, BAYQ6256) DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting to Everest ER with frostbites during peak climbing seasons will be evaluated and undergo grading according to Cauchy classification. If they present with grades 3 or 4 frostbite(s) they will be offered to participate.

You may qualify if:

• Frostbite grade 3/4 eligible for Iloprost
• \<72h of thawing
• min. age of 18 years
• provision of written informed consent

You may not qualify if:

• age \<18 years
• general contraindication
• pregnancy
• inability/denial to provide informed consent

Sponsors & Collaborators

• Institute of Mountain Emergency Medicine: lead

Study Sites (1)

Eurac Research, Institute of Mountain Emergency Medicine

Bolzano, BZ, 39100, Italy

Location

MeSH Terms

Conditions

Frostbite

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Cold Injury; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Central Study Contacts

Lea AJ Duempelmann

CONTACT

+39 0471 055 726; lea.duempelmann@eurac.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)