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

NCT ID: NCT07248930

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-03-31

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.

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

Conditions

Burns

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Baseline therapy + Efferon LPS NEO

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

Efferon LPS NEO

Intervention Type: 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.

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.

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan Afukov, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Filatov Children's City Clinical Hospital of the Moscow Health Department

Locations

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

Moscow, , Russia

Site Status: RECRUITING

Children's municipal multi-specialty clinical center of high medical technology

Saint Petersburg, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

Role: CONTACT

alexandr.shelehov@gmail.com

+79636564765

Facility Contacts

Anastasia Chashchukhina, PhD, MDC

Role: primary

chashyxina@yandex.ru

Mikhail Rusak, PhD,MD

Role: primary

rusakneo@gmail.com

Other Identifiers

efferon-lps-2025-03

Identifier Type: -

Identifier Source: org_study_id