Hemoadsorption with Efferon LPS NEO for children with large thermal burns
An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns
This pilot tests whether hemoadsorption using the Efferon LPS NEO device can help children with large thermal burns by removing endotoxins and other inflammatory mediators to reduce complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 1 Year to 14 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 2 sites (Moscow and 1 other locations) |
| Trial ID | NCT07248930 on ClinicalTrials.gov |
What this trial studies
This observational pilot enrolls pediatric patients with extensive second- and third-degree thermal burns and prospectively treats them with two hemoadsorption sessions using the Efferon LPS NEO device, with a retrospectively selected control group for comparison. Each treatment involves two 6–12 hour adsorption sessions separated by 24–120 hours and may be combined with hemofiltration or hemodiafiltration at the investigator's discretion. The device targets both pathogen-associated (endotoxin) and damage-associated inflammatory mediators, a mechanism developed for sepsis that may be relevant in burn-induced systemic inflammation. The primary goal is to identify objective criteria for judging whether hemoadsorption is effective in pediatric burn care rather than to establish definitive clinical benefit.
Who should consider this trial
Good fit: Children with second- or third-degree thermal burns covering at least 40% of total body surface area who can begin hemoadsorption within five days of ICU admission and tolerate at least a six-hour treatment session.
Not a fit: Patients with end-stage renal disease, recent uncontrolled bleeding, acute pulmonary embolism, or those unable to tolerate prolonged extracorporeal therapy are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If effective, hemoadsorption could lower rates of sepsis and inflammatory complications and improve recovery and survival in children with extensive burns.
How similar studies have performed: Hemoadsorption devices have shown promise in adult sepsis and some adult burn reports, but controlled pediatric data are limited and this approach remains under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29) * Frank index \>90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion) * Start of hemoadsorption no later than 5 days after admission to the ICU * The patient should receive adequate infusion therapy (at least 30 mL/kg) from the moment of inclusion in the study until the first sorption * The patient's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours Exclusion Criteria: * Presence of end-stage renal disease * Acute pulmonary embolism, confirmed by CT scan * Uncontrolled bleeding (acute blood loss within the last 24 hours)
Where this trial is running
Moscow and 1 other locations
- Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department — Moscow, Russia (Recruiting)
- Children's municipal multi-specialty clinical center of high medical technology — Saint Petersburg, Russia (Recruiting)
Study contacts
- Principal investigator: Ivan Afukov, PhD, MD — Filatov Children's City Clinical Hospital of the Moscow Health Department
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +79636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.