Efferon LPS hemoadsorption for severe burns

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and potential benefit of multimodal hemoadsorption using the Efferon LPS device in burn patients with a high risk of organ dysfunction. Participants are randomized to receive standard baseline therapy (including CRRT) or baseline therapy plus Efferon LPS hemoadsorption for at least 6 hours within 10 days of injury. The trial targets patients with extensive burns and a revised Frank index between 71 and 181, aiming to reduce systemic inflammation and progression to multiple organ dysfunction. Burn injury triggers a systemic inflammatory response that can lead to organ failure and death, and this approach seeks to attenuate that response by removing cytokines and LPS. Safety and efficacy outcomes will inform whether this extracorporeal therapy can improve clinical trajectories in severe burn care.

Why it matters

Who can join: the full rules

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

Where it's running

• N.V. Sklifosovsky Research Institute for Emergency Medicine
  Moscow, Russia Recruiting

Study contacts

• Principal investigator: Vladimir Kulabukhov, PhD, MD — N.V. Sklifosovsky Research Institute for Emergency Medicine
• Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
• Email: ais@efferon.ru
• Phone: +79636564765

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.