Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

NCT ID: NCT07259668

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2028-03-31

Brief Summary

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.

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.

Conditions

Burns

Study Design

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

Study Groups

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

Baseline therapy + Efferon LPS

Patients will receive standard therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollment.

Efferon LPS

Intervention Type: DEVICE

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.

Interventions

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.

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Efferon JSC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Igor Samatov, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

State Novosibirsk Regional Clinical Hospital

Alexander Mezhin, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

State Novosibirsk Regional Clinical Hospital

Vladimir Kulabukhov, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

NV Sklifosovsky Research Institute for Emergency Medicine

Locations

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

Role: CONTACT

alexandr.shelehov@gmail.com

+79636564765

Facility Contacts

Igor Samatov, PhD, MD

Role: primary

isamatov67@gmail.com

+79139084409

Other Identifiers

efferon-lps 2025-03.1

Identifier Type: -

Identifier Source: org_study_id