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

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.

Study Overview

• Status: Recruiting
• Conditions: Burns
• Intervention / Treatment: Device: Efferon LPS NEO

Detailed Description

Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Alexandr Shelehov-Kravchenko, PhD, MD; Phone Number: +79636564765; Email: alexandr.shelehov@gmail.com

Study Locations

• Russia
  • Moscow, Russia, 123317
    • Recruiting
    • Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department
    • Contact: Anastasia Chashchukhina, PhD, MDC; Email: chashyxina@yandex.ru
  • Saint Petersburg, Russia
    • Recruiting
    • Children's municipal multi-specialty clinical center of high medical technology
    • Contact: Mikhail Rusak, PhD,MD; Email: rusakneo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with thermal burns undergoing treatment in Children's City Clinical Hospital No. 9 named after G.N. Speransky and Children's municipal multi-specialty clinical center of high medical technology

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Baseline therapy + Efferon LPS NEO; Patients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement.	Device: Efferon LPS NEO; 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.
Control group; The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU length of stay	Time (days) from the start of hemoadsorption to transfer from the ICU	1-28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support	Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score)	1-28 days
Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function	Value of oxygenation index (Pa02 / Fi02 (Pa))	1-28 days
Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance	Cummulative fluid balance in mL/kg	1-28 days
Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)	Duration of renal replacement therapy (RRT) in hours	1-28 days
Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions	Frequency of surgical interventions (necrectomy)	1-28 days
Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality	Mortality rate	1-28 days

Collaborators and Investigators

• Sponsor: Efferon JSC
• Investigators: Principal Investigator: Ivan Afukov, PhD, MD, Filatov Children's City Clinical Hospital of the Moscow Health Department

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Hemoperfusion; Hemoadsorption; LPS adsorption; Extracorporeal therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: efferon-lps-2025-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No