Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

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

This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into 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 a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.

Study Overview

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

Detailed Description

Extensive burns represent 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 leading contributors to mortality among severely burned patients.

The Efferon LPS device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which involves a complex systemic inflammatory response. Burn trauma induces the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may lead to the appearance of pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore essential for effective burn injury management. The aim of this study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

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

Study Locations

• Russia
  • Novosibirsk, Russia, 630087
    • Recruiting
    • State Novosibirsk regional clinical hospital
    • Contact: Igor Samatov, PhD, MD; Phone Number: +79139084409; Email: isamatov67@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with thermal burns undergoing treatment in State Novosibirsk Regional Clinical Hospital

Description

Inclusion Criteria:

• Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29)
• Burn disease in the stage of acute toxemia or septicemia
• Frank Index ≥ 90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
• The patient's condition allows for Efferon LPS therapy for at least 6 hours

Exclusion Criteria:

• Isolated thermal inhalation injury
• Charlson Comorbidity Index > 8
• Dementia
• End-stage renal failure
• Acute pulmonary embolism confirmed by CT
• Acute myocardial infarction within the past 4 weeks
• Acute cerebrovascular accident
• Uncontrolled bleeding (acute blood loss within the past 24 hours)
• Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Baseline therapy + Efferon LPS; Patients will receive standard therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollment.	Device: Efferon LPS; Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the Efferon LPS hemoadsorption on 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 hemoadsoption on length of hospital stay	Length of hospital stay	1-60 days
Effect of the Efferon LPS hemoadsorption on need for vasopressor support	Need for vasopressors according to the VIS 2020 scale (Vasoactive-Inotropic Score), a weighted sum of vasoactive and inotropic medication doses; higher scores indicate greater hemodynamic support requirement (worse outcome).	1-28 days
Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function	Value of oxygenation index (PaO₂/FiO₂ (Pa)) Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).	1-28 days
Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)	Duration of renal replacement therapy (RRT) in hours	1-28 days
Effect of the Efferon LPS hemoadsorption on incidence of septic complications	Frequency of septic complications	1-28 days
Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions	Frequency of surgical interventions	1-28 days
Effect of the Efferon LPS hemoadsoption on 28-day mortality	Mortality rate	1-28 days

Collaborators and Investigators

• Sponsor: Efferon JSC
• Investigators: Principal Investigator: Igor Samatov, PhD, MD, State Novosibirsk regional clinical hospital; Principal Investigator: Alexander Mezhin, PhD, MD, State Novosibirsk regional clinical hospital; Principal Investigator: Vladimir Kulabukhov, PhD, MD, NV Sklifosovsky Research Institute for Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

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 2025-03.1

Drug and device information, study documents

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