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NCT Number: NCT07248930

Lipopolysaccharide Adsorption (Efferon LPS NEO) 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.

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Key information

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department, Moscow, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Efferon LPS NEO

Device

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.

Primary outcomes

  1. ICU length of stay

    Time frame: 1-28 days

    Time (days) from the start of hemoadsorption to transfer from the ICU

Secondary outcomes

  1. Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support

    Time frame: 1-28 days

    Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score)

  2. Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function

    Time frame: 1-28 days

    Value of oxygenation index (Pa02 / Fi02 (Pa))

  3. Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance

    Time frame: 1-28 days

    Cummulative fluid balance in mL/kg

  4. Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)

    Time frame: 1-28 days

    Duration of renal replacement therapy (RRT) in hours

  5. Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions

    Time frame: 1-28 days

    Frequency of surgical interventions (necrectomy)

  6. Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality

    Time frame: 1-28 days

    Mortality rate

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

[email protected]

+79636564765

Sponsors and collaborators

Lead sponsor

Efferon JSC

Industry

Registry information

Official study title

An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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