An interventional study of Efferon LPS in Burns, sponsored by Efferon JSC. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Efferon JSC · Not applicable, Interventional, and Treatment
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.
Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Burn injury is not only a local tissue injury at the site of the damaging agent, but also triggers a complex systemic response to trauma. Severe burn injury induces a systemic inflammatory response associated with generalized microcirculatory disturbances in organs and tissues, cellular dystrophy and destruction, and the development of multiple organ dysfunction and failure. Burn trauma causes massive release of damage-associated molecular patterns (DAMPs) and pro-inflammatory cytokines, leading to systemic inflammatory response syndrome (SIRS), which may result in multiple organ failure and death. Mortality associated with multiple organ failure in burn patients reaches 81-87% among patients who develop this condition, and multiple organ failure remains the leading cause of death in burn patients. Among patients with a Sequential Organ Failure Assessment (SOFA) score ≥4 within the first 24 hours after injury, mortality reaches 81%.
The Efferon LPS hemoadsorption device was developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential in the treatment of burn injury, a condition characterized by a complex inflammatory response.
The goal of this 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 manifestations and to prevent progression of multiple organ dysfunction, or mitigate it if already developed, in patients with burn disease and an RFI score ≥71 and ≤181.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 50 is above the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →Efferon JSC is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receiving standard treatment for the treatment of thermal burns without the use of hemoadsorption methods, but who are prescribed continuous renal replacement therapy (CRRT) for renal and non-renal indications.
Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT).
Device: Efferon LPS
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.hemoadsorption procedures, each lasting 6-12 hours, with an interval of at least 24 hours between hemoadsorption sessions (from the start of the first procedure). The procedures are performed in combination with continuous renal replacement therapy (CRRT).
Need for vasopressor support
Need for vasopressors according to the Vasoactive inotropic score (VIS 2020) heart rate scale. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.
Time frame: 1-28 days
Horowitz oxygenation index
Value of oxygenation index (Pa02 / Fi02 (Pa).
Time frame: 1-28 days
Renal replacement therapy (RRT) free days
RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. RRT-free days = 0 if the subject requires RRT for more than 28 days.
Time frame: 1-28 days
28 and 60 days mortality
Mortality rate
Time frame: 1-60 days
Length of stay in the intensive care unit
Time (number of days) from study enrollment to transfer from the intensive care unit within 60 days
Time frame: 1-60 days
Duration of hospitalization
Time (number of days) from study enrollment to discharge from the hospital
Time frame: 1-60 days
Frequency of septic complications
Percentage of patients with septic complications
Time frame: 1-28 days
Frequency of surgical interventions
Percentage of patients requiring surgery
Time frame: 1-28 days
Started Oct 2026 (actual). Primary completion is estimated for Dec 2027, 14 months after the start.
Of 29 industry-sponsored interventional studies with no phase under Burns, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's planned 14 months is above that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
Start moved once since we started tracking on Sep 25, 2026: May 2026 → Oct 2026, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
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 ↗
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Efferon JSC