An observational study in Burns, sponsored by Efferon JSC. Withdrawn at 2 sites in Russia. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Efferon JSC · Observational
No patients meeting the study eligibility criteria were identified
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to 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 an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury
905 studies on the registry are indexed under Burns; 164 are open to participants now.
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Pediatric patients with thermal burns undergoing treatment in Children's City Clinical Hospital No. 9 named after G.N. Speransky and Children's municipal multi-specialty clinical center of high medical technology
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Exclusion Criteria:
Patients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement.
Device: Efferon LPS NEO
The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures.
Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.
ICU length of stay
Time (days) from the start of hemoadsorption to transfer from the ICU
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support
Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score)
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function
Value of oxygenation index (Pa02 / Fi02 (Pa))
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance
Cummulative fluid balance in mL/kg
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)
Duration of renal replacement therapy (RRT) in hours
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions
Frequency of surgical interventions (necrectomy)
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality
Mortality rate
Time frame: 1-28 days
No patients meeting the study eligibility criteria were identified
No patients meeting the study eligibility criteria were identified
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is withdrawn, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Efferon JSC