BurnsNCT07248930
Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns
An observational study of Burns, run by Efferon JSC at 2 sites in Russia.
Trial summary
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to the treatment group and compared with a retrospectively selected control group. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Burns
- What is being tested?
- Efferon LPS NEO
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 2 sitesRussia
- Study dates
- 1 Oct 2025to 31 Mar 2027
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients with thermal burns undergoing treatment in Children's City Clinical Hospital No. 9 named after G.N. Speransky and Children's municipal multi-specialty clinical center of high medical technology
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)
- Frank index >90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
- Start of hemoadsorption no later than 5 days after admission to the ICU
- The patient should receive adequate infusion therapy (at least 30 mL/kg) from the moment of inclusion in the study until the first sorption
- The patient's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours
Who cannot join
- Presence of end-stage renal disease
- Acute pulmonary embolism, confirmed by CT scan
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department
Moscow, 123317
Children's municipal multi-specialty clinical center of high medical technology
Saint Petersburg
About this study
Official title: An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns
This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to 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 an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
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. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury
- Conditions
- Burns
- Being tested
- Efferon LPS NEO
- 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 LPS NEODevice
Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 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 |
|---|---|---|
| Baseline therapy + Efferon LPS NEO | Patients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement. Receives: Device: Efferon LPS NEO | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU length of stay
Time (days) from the start of hemoadsorption to transfer from the ICU
Measured: 1-28 days
Secondary outcomes (6)
Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support
Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score)
Measured: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function
Value of oxygenation index (Pa02 / Fi02 (Pa))
Measured: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance
Cummulative fluid balance in mL/kg
Measured: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)
Duration of renal replacement therapy (RRT) in hours
Measured: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions
Frequency of surgical interventions (necrectomy)
Measured: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality
Mortality rate
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 posted25 Nov 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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
- Ivan Afukov, PhD, MD, Principal investigator, Filatov Children's City Clinical Hospital of the Moscow Health Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248930
- Sponsor's protocol ID
- efferon-lps-2025-03
- Status last verified
- Oct 2026
- First submitted
- 18 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 NEO Device in Children With Thermal Burns
- ClinicalTrials.gov ID
- NCT07248930
- Acronym / sponsor ID
- efferon-lps-2025-03
- 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
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Nov 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 identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to 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 an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.
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. Despite advances in modern medicine, sepsis and other infectious complications remain the leading causes of high mortality among severely burned patients. The Efferon® LPS NEO device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which is characterized by a complex inflammatory response. Burn trauma triggers the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may introduce pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore critical for effective burn injury management. The goal of the study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy + Efferon LPS NEO | – | Device: Efferon LPS NEOPatients will receive standart therapy for thermal burns treatments and Efferon LPS NEO hemoadsorption procedure. Prospective enrollement. |
| 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. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients with thermal burns undergoing treatment in Children's City Clinical Hospital No. 9 named after G.N. Speransky and Children's municipal multi-specialty clinical center of high medical technology
Key inclusion criteria (5 listed)
- Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29)
- Frank index >90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
- Start of hemoadsorption no later than 5 days after admission to the ICU
- The patient should receive adequate infusion therapy (at least 30 mL/kg) from the moment of inclusion in the study until the first sorption
- The patient's condition allows Efferon LPS NEO therapy to be performed for at least 6 hours
Key exclusion criteria (3 listed)
- Presence of end-stage renal disease
- Acute pulmonary embolism, confirmed by CT scan
- Uncontrolled bleeding (acute blood loss within the last 24 hours)
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 LPS NEOEfferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator. | Device | Baseline therapy + Efferon LPS NEO |
Primary outcome
ICU length of stay
Time frame: 1-28 days
Time (days) from the start of hemoadsorption to transfer from the ICU
6 secondary outcomes
Effect of the Efferon LPS NEO hemoadsoption on need for vasopressor support
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on pulmonary oxygen metabolic function
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on cummulative fluid balance
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on duration of renal replacement therapy (RRT)
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on frequency of surgical interventions
Time frame: 1-28 days
Effect of the Efferon LPS NEO hemoadsoption on 28 days mortality
Time frame: 1-28 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.
Ivan Afukov, PhD, MD principal investigator
Filatov Children's City Clinical Hospital of the Moscow Health Department
2 sites 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 2 sites 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 5 inclusion and 3 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 2 sites 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?
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.