Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With 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
Efferon JSC
30 participants
Oct 1, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria3
- Presence of end-stage renal disease
- Acute pulmonary embolism, confirmed by CT scan
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
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Interventions
Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.
Locations(2)
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NCT07248930