NCT07248930 Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns
| NCT ID | NCT07248930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Efferon JSC |
| Condition | Burns |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-10-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
Eligibility 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)
Contact & Investigator
Ivan Afukov, PhD, MD
PRINCIPAL INVESTIGATOR
Filatov Children's City Clinical Hospital of the Moscow Health Department
Frequently Asked Questions
Who can join the NCT07248930 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 14 Years, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07248930 currently recruiting?
Yes, NCT07248930 is actively recruiting participants. Contact the research team at alexandr.shelehov@gmail.com for enrollment information.
Where is the NCT07248930 trial being conducted?
This trial is being conducted at Moscow, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT07248930 clinical trial?
NCT07248930 is sponsored by Efferon JSC. The principal investigator is Ivan Afukov, PhD, MD at Filatov Children's City Clinical Hospital of the Moscow Health Department. The trial plans to enroll 30 participants.