Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns
An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
Efferon JSC
15 participants
Dec 8, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria9
- 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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Interventions
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. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.
Locations(1)
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NCT07259668