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Withdrawn NCT07259668

Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

Conditions: Burns

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Sponsor: Efferon JSC

Location: State Novosibirsk Regional Clinical Hospital Novosibirsk

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07259668). StuddyBuddy aggregates publicly available trial information.