Efferon LPS Hemoadsorption in in Patients With Thermal Burns

NCT07568132 | Not Yet Recruiting

• 1 other identifier: efferon-lps-2026-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181. Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.

Conditions

Burns

Keywords

Hemoadsorption; Hemoperfusion; Extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (1)

• Need for vasopressor support

  Need for vasopressors according to the Vasoactive inotropic score (VIS 2020) heart rate scale. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.

  1-28 days

Secondary Outcomes (7)

• Horowitz oxygenation index

  1-28 days

• Renal replacement therapy (RRT) free days

  1-28 days

• 28 and 60 days mortality

  1-60 days

• Length of stay in the intensive care unit

  1-60 days

• Duration of hospitalization

  1-60 days

Study Arms (2)

Baseline therapy

NO INTERVENTION

Patients receiving standard treatment for the treatment of thermal burns without the use of hemoadsorption methods, but who are prescribed continuous renal replacement therapy (CRRT) for renal and non-renal indications.

Baseline therapy + Efferon LPS

EXPERIMENTAL

Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT).

Device: Efferon LPS

Interventions

Efferon LPS 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.hemoadsorption procedures, each lasting 6-12 hours, with an interval of at least 24 hours between hemoadsorption sessions (from the start of the first procedure). The procedures are performed in combination with continuous renal replacement therapy (CRRT).

Baseline therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thermal burns (flame, scald, or contact burns), including cases combined with inhalation injury
• Revised Frank Index (RFI) score ≥71 and ≤181
• Indication for extracorporeal therapy within the first 10 days after injury
• The patient's condition allows Efferon LPS therapy to be performed for at least 6 hours

You may not qualify if:

• Isolated thermal-inhalation injury
• Chemical, electrical, or solar burns of the skin
• Combined skin burns with frostbite and/or general hypothermia
• Combined trauma (electrical injury; traumatic brain injury other than concussion or mild cerebral contusion; skull, spinal, thoracic, pelvic, or femoral fractures) or acute pre-existing pathology prior to hospital admission (acute myocardial infarction, stroke, community-acquired pneumonia, or acute surgical conditions) that may influence the course and outcome of burn disease
• Cardiopulmonary resuscitation at the pre-hospital stage
• End-stage renal disease
• Acute pulmonary embolism confirmed by imaging
• Emergency surgical treatment

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

N.V. Sklifosovsky Research Institute for Emergency Medicine

Moscow, 129090, Russia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Vladimir Kulabukhov, PhD, MD

  N.V. Sklifosovsky Research Institute for Emergency Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; ais@efferon.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 27, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

RU (1)