Efferon LPS Hemoadsorption in in Patients With Thermal Burns

Official title

Extracorporeal Blood Purification Using Efferon LPS Hemoadsorption in Patients With Thermal Burns: Pilot Study

Overview

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.

Detailed description

Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Burn injury is not only a local tissue injury at the site of the damaging agent, but also triggers a complex systemic response to trauma. Severe burn injury induces a systemic inflammatory response associated with generalized microcirculatory disturbances in organs and tissues, cellular dystrophy and destruction, and the development of multiple organ dysfunction and failure. Burn trauma causes massive release of damage-associated molecular patterns (DAMPs) and pro-inflammatory cytokines, leading to systemic inflammatory response syndrome (SIRS), which may result in multiple organ failure and death. Mortality associated with multiple organ failure in burn patients reaches 81-87% among patients who develop this condition, and multiple organ failure remains the leading cause of death in burn patients. Among patients with a Sequential Organ Failure Assessment (SOFA) score ≥4 within the first 24 hours after injury, mortality reaches 81%.

The Efferon LPS hemoadsorption device was developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential in the treatment of burn injury, a condition characterized by a complex inflammatory response.

The goal of this 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 manifestations and to prevent progression of multiple organ dysfunction, or mitigate it if already developed, in patients with burn disease and an RFI score ≥71 and ≤181.

Interventions

• 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.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).

Primary outcome measures

• Need for vasopressor support [Time frame: 1-28 days]

Secondary outcome measures (7)

• Horowitz oxygenation index [Time frame: 1-28 days]
• Renal replacement therapy (RRT) free days [Time frame: 1-28 days]
• 28 and 60 days mortality [Time frame: 1-60 days]
• Length of stay in the intensive care unit [Time frame: 1-60 days]
• Duration of hospitalization [Time frame: 1-60 days]
• Frequency of septic complications [Time frame: 1-28 days]
• Frequency of surgical interventions [Time frame: 1-28 days]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• Any other condition which, in the investigator's opinion, precludes inclusion of the patient in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Russia · 1 center

• N.V. Sklifosovsky Research Institute for Emergency Medicine — Moscow

Identifiers

NCT: NCT07568132 · efferon-lps-2026-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗