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

NCT07248930 | Recruiting

• 1 other identifier: efferon-lps-2025-03
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns

Keywords

Hemoadsorption; Hemoperfusion; Extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (1)

• ICU length of stay

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

  1-28 days

Secondary Outcomes (6)

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

  1-28 days

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

  1-28 days

• Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance

  1-28 days

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

  1-28 days

• Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions

  1-28 days

Study Arms (2)

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

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.

Interventions

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.

Baseline therapy + Efferon LPS NEO

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours

You may not qualify if:

• Presence of end-stage renal disease
• Acute pulmonary embolism, confirmed by CT scan
• Uncontrolled bleeding (acute blood loss within the last 24 hours)

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (2)

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

Moscow, 123317, Russia

RECRUITING

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

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Ivan Afukov, PhD, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

RU (2)