BurnsNCT07259668
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns
An observational study of Burns, run by Efferon JSC at 1 site in Russia.
Trial summary
This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into the treatment group and compared with a retrospectively selected control group. 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
- How many people
- 0 participants
- Where
- 1 siteRussia
- Study dates
- 8 Dec 2025to 31 Mar 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Adult patients with thermal burns undergoing treatment in State Novosibirsk Regional Clinical Hospital
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.
Read the detailed description
Extensive burns represent a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain leading contributors to mortality among severely burned patients.
The Efferon LPS device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which involves a complex systemic inflammatory response. Burn trauma induces the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may lead to the appearance of pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore essential for effective burn injury management. The aim of this study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury.
- 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. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Control group | The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures. | |
| Baseline therapy + Efferon LPS | Patients will receive standard therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollment. Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of the Efferon LPS hemoadsorption on ICU length of stay
Time (days) from the start of hemoadsorption to transfer from the ICU
Measured: 1-28 days
Secondary outcomes (7)
Effect of the Efferon LPS hemoadsorption on need for vasopressor support
Need for vasopressors according to the VIS 2020 scale (Vasoactive-Inotropic Score), a weighted sum of vasoactive and inotropic medication doses; higher scores indicate greater hemodynamic support requirement (worse outcome).
Measured: 1-28 days
Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function
Value of oxygenation index (PaO₂/FiO₂ (Pa))
Oxygenation index (PaO₂/FiO₂) = arterial oxygen partial pressure (Pa02, mmHg) / the fraction of inspired oxygen (FiO2).
Measured: 1-28 days
Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)
Duration of renal replacement therapy (RRT) in hours
Measured: 1-28 days
Effect of the Efferon LPS hemoadsorption on incidence of septic complications
Frequency of septic complications
Measured: 1-28 days
Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions
Frequency of surgical interventions
Measured: 1-28 days
Effect of the Efferon LPS hemoadsoption on 28-day mortality
Mortality rate
Measured: 1-28 days
Effect of the Efferon LPS hemoadsoption on length of hospital stay
Length of hospital stay
Measured: 1-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start8 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Why it stopped: No patients meeting the study eligibility criteria were identified
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Samatov, PhD, MD, Principal investigator, State Novosibirsk Regional Clinical HospitalAlexander Mezhin, PhD, MD, Principal investigator, State Novosibirsk Regional Clinical HospitalVladimir Kulabukhov, PhD, MD, Principal investigator, NV Sklifosovsky Research Institute for Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259668
- Sponsor's protocol ID
- efferon-lps 2025-03.1
- Status last verified
- Oct 2026
- First submitted
- 21 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
- ClinicalTrials.gov ID
- NCT07259668
- Acronym / sponsor ID
- efferon-lps 2025-03.1
- Conditions
- Burns
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients meeting the study eligibility criteria were identified
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.
Detailed description
Extensive burns represent a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain leading contributors to mortality among severely burned patients.
The Efferon LPS device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which involves a complex systemic inflammatory response. Burn trauma induces the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may lead to the appearance of pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore essential for effective burn injury management. The aim of this study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures. |
| Baseline therapy + Efferon LPS | – | Device: Efferon LPSPatients will receive standard therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with thermal burns undergoing treatment in State Novosibirsk Regional Clinical Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Isolated thermal inhalation injury
- Charlson Comorbidity Index > 8
- Dementia
- End-stage renal failure
- Acute pulmonary embolism confirmed by CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon LPSEfferon 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. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator. | Device | Baseline therapy + Efferon LPS |
Primary outcome
Effect of the Efferon LPS hemoadsorption on ICU length of stay
Time frame: 1-28 days
Time (days) from the start of hemoadsorption to transfer from the ICU
7 secondary outcomes
Effect of the Efferon LPS hemoadsorption on need for vasopressor support
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsorption on incidence of septic complications
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsoption on 28-day mortality
Time frame: 1-28 days
Effect of the Efferon LPS hemoadsoption on length of hospital stay
Time frame: 1-60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor Samatov, PhD, MD principal investigator
State Novosibirsk Regional Clinical Hospital
Alexander Mezhin, PhD, MD principal investigator
State Novosibirsk Regional Clinical Hospital
Vladimir Kulabukhov, PhD, MD principal investigator
NV Sklifosovsky Research Institute for Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Efferon JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the Efferon LPS hemoadsorption on ICU length of stay (time frame: 1-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.