Efferon LPS Hemoadsorption in in Patients With Thermal Burns
ConditionBurns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEfferon JSC
About this trial
The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181.
Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efferon LPS
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov