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Recruiting NCT07568132

Efferon LPS Hemoadsorption in in Patients With Thermal Burns

Conditions: Burns

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Efferon JSC

Location: N.V. Sklifosovsky Research Institute for Emergency Medicine Moscow

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.

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07568132). StuddyBuddy aggregates publicly available trial information.