Efferon LPS hemoadsorption for adults with extensive thermal burns
An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
This pilot will try using the Efferon LPS blood-filtering device in adults with large thermal burns to see if it reduces harmful inflammation and related complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 1 site (Novosibirsk) |
| Trial ID | NCT07259668 on ClinicalTrials.gov |
What this trial studies
This observational pilot will prospectively enroll adults with extensive second- and third-degree thermal burns to receive two hemoadsorption sessions with the Efferon LPS device and compare their outcomes with a retrospectively selected control group. Each treatment consists of two 6–12 hour hemoadsorption sessions spaced 24 hours apart, and procedures may be combined with hemofiltration or hemodiafiltration at the investigator's discretion. The device is designed to remove both damage- and pathogen-associated inflammatory mediators that contribute to systemic inflammation and sepsis after severe burns. The aim is to identify practical criteria and signals of effectiveness for hemoadsorption in the burn population to guide future controlled trials.
Who should consider this trial
Good fit: Adults with thermal second- or third-degree burns affecting 40% or more of total body surface area who are in the acute toxemia or septicemia stage and can tolerate at least 6 hours of Efferon LPS therapy.
Not a fit: Patients with isolated inhalation injury, high comorbidity burden (Charlson index >8), dementia, end-stage renal failure, recent major cardiovascular or cerebrovascular events, uncontrolled bleeding, or other investigator-determined contraindications are unlikely to benefit.
Why it matters
Potential benefit: If effective, Efferon LPS hemoadsorption could reduce inflammatory mediators and lower the risk of sepsis and organ complications in severely burned patients.
How similar studies have performed: Hemoadsorption devices including LPS-targeting cartridges have shown promise in sepsis and small inflammatory-condition studies, but robust evidence for benefit specifically in major burn patients is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Novosibirsk
- State Novosibirsk Regional Clinical Hospital — Novosibirsk, Russia (Recruiting)
Study contacts
- Principal investigator: Igor Samatov, PhD, MD — State Novosibirsk Regional Clinical Hospital
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +79636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.