Field Study on Intravenous Iloprost for Treatment of Severe Frostbite at High Altitude
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute of Mountain Emergency Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Frostbite grade 3/4 eligible for Iloprost
<72h of thawing
min. age of 18 years
provision of written informed consent
Disqualifiers
age <18 years
general contraindication
pregnancy
inability/denial to provide informed consent
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Iloprost (Ilomedin, BAYQ6256)
DrugBegin 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 (%)
Time frame
from enrolment to the end of treatment at 1 week2
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 (%)
Time frame
From enrolment to 1 week after beginning of treatment3
Time from thawing to initiation of iloprost treatment under field conditions
Unit/format: time (hours or minutes)
Time frame
From enrolment to the end of treatment at day 14
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.
Time frame
From enrollment to the end of treatment at 1 weekSecondary outcomes
1
Baseline tissue at risk for amputation (Hennepin Frostbite Score at-risk component)
Baseline tissue at risk will be quantified using the Hennepin Frostbite Score at-risk component, documented at initial assessment (before 1st treatment administration). Results will be summarised as score values (mean \[SD\]).
Time frame
From enrolment to 1 week after treatment initiation2
Overall digital salvage rate at 6 and 12 months (Hennepin Frostbite Score-defined digits at risk vs amputated) after treatment completion
At 6 and 12 months, the digital salvage rate will be calculated as the proportion of digits at risk that are not amputated, where "digits at risk" and "amputated" are determined using the Hennepin Frostbite Score methodology and follow-up documentation. Results will be reported as n/N and % with 95% confidence intervals, and may be compared with prespecified historical proportions from the literature (one-sample proportion testing as applicable).
Time frame
From enrolment to 18 months after treatment completion3
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)
Amputation status (any vs none) will be ascertained from clinical charts, operative notes and self reports at six and twelve months after treatment completion. Results will be reported as n (%) with 95% confidence intervals, and may be compared with pre-specified historical rates from the literature if feasible.
Time frame
from enrollment to follow ups up to 18 months after discharge.4
Number of joints salvaged per participant at 6 and 12 months (Hennepin Frostbite Score-based joint tissue at risk vs amputated)
At 6 and 12 months after treatment completion, the number of joints salvaged per participant will be determined from the Hennepin Frostbite Score tissue-at-risk mapping and documented final tissue loss/amputation level. Results will be summarized per participant (e.g., mean \[SD\] and/or distributional summaries) at each timepoint.
Time frame
From enrolment to 18 months after dischargeSponsors and contacts
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Source ClinicalTrials.gov
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