BurnsNCT07568132
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
A study testing Efferon LPS in people with Burns, run by Efferon JSC at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Efferon LPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 21 Oct 2026to 27 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090
Vladimir Kulabukhov, PhD, MD, +79255068081, v.kulabukhov@gmail.com
About this study
Official title: Extracorporeal Blood Purification Using Efferon LPS Hemoadsorption in Patients With Thermal Burns: Pilot Study
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.
Read the detailed description
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.
- Conditions
- Burns
- Being tested
- Efferon LPS
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon LPSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Baseline therapy | No intervention | 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. |
| Baseline therapy + Efferon LPS | Experimental | Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT). Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-28 days
Secondary outcomes (7)
Horowitz oxygenation index
Value of oxygenation index (Pa02 / Fi02 (Pa).
Measured: 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.
Measured: 1-28 days
28 and 60 days mortality
Mortality rate
Measured: 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
Measured: 1-60 days
Duration of hospitalization
Time (number of days) from study enrollment to discharge from the hospital
Measured: 1-60 days
Frequency of septic complications
Percentage of patients with septic complications
Measured: 1-28 days
Frequency of surgical interventions
Percentage of patients requiring surgery
Measured: 1-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start21 Oct 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Kulabukhov, PhD, MD, Principal investigator, N.V. Sklifosovsky Research Institute for Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568132
- Sponsor's protocol ID
- efferon-lps-2026-01
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No