Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns

Efferon

Status: Enrolling

Conditions: Burns

Treatments: Device: Efferon LPS NEO

Study type: Observational

Funder types: Industry

Identifiers

NCT07248930

efferon-lps-2025-03

Details and patient eligibility

About

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.

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 2 patient groups

Baseline therapy + Efferon LPS NEO

Description:

Patients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement.

Treatment:

Device: Efferon LPS NEO

Control group

Description:

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.