NCT07259668

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Efferon JSC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-08
• Primary completion: 2027-12-31
• Completion: 2028-03-31
• First posted: 2025-12-02
• Last updated: 2026-01-22

Locations

1 site across 1 country: Russia