Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

Efferon

Status: Enrolling

Conditions: Burns

Treatments: Device: Efferon LPS

Study type: Observational

Funder types: Industry

Identifiers

NCT07259668

efferon-lps 2025-03.1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 2 patient groups

Control group

Description:

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

Description:

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

Treatment:

Device: Efferon LPS