Cardiac DiseaseNCT07532174
Efferon LPS Hemoadsorption in Cardiac Surgery Patients
A study testing Efferon LPS in people with Cardiac Disease and Multiple Organ Dysfunction Syndrome, run by Efferon JSC at 3 sites in Russia.
Trial summary
This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Multiple Organ Dysfunction Syndrome
- 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
- 60 participants
- Where
- 3 sitesRussia
- Study dates
- 22 Apr 2026to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
- EuroSCORE II ≥6%
Who cannot join
- Procalcitonin ≥2 ng/mL
- Severe chronic liver disease, defined as Child-Pugh class C (>10 points) or clinically manifest hepatic failure
- Dialysis-dependent chronic kidney disease (CKD)
- Ongoing immunosuppressive therapy, including corticosteroids or cytotoxic agents, excluding standard perioperative medications
- Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Russia3 sites, 3 recruiting
- Recruiting
Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary"
Barnaul
Alexander Efremushkin, PhD, MD, zavoar1@akkd.ru
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg
Andrey Bautin, PhD, MD, bautin_ae@almazovcentre.ru
- Recruiting
Pavlov First Saint Petersburg State Medical University
Saint Petersburg
Yuri Polushin, PhD, MD, polushin1@gmail.com
About this study
Official title: Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period
This randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
Read the detailed description
Annually, over 1 million people worldwide undergo cardiac surgery. Most cardiac procedures still require cardiopulmonary bypass (CPB), myocardial protection during aortic cross-clamping, and the induction of cardioplegic arrest by administering cardioplegic solutions into the coronary circulation. All of these factors contribute to ischemia-reperfusion injury of the myocardium, which remains a leading cause of acute heart failure following the restoration of spontaneous circulation and, consequently, the development of post-perfusion multiple organ dysfunction, particularly acute kidney injury (AKI).
AKI occurs in approximately 7% of all hospitalized patients, 30% of intensive care unit patients, and up to 30% of patients undergoing cardiac surgery. Endotoxemia is one of the major contributors to the development of AKI. Septic AKI, compared with non-septic AKI, is associated with poorer prognosis, longer hospital stays, and lower survival rates.
The goal of the study is to evaluate the safety and efficacy of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period.
- Being tested
- Efferon LPS
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Medical subject headings
- Heart Diseases, Multiple Organ Failure
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.
Efferon LPS hemoadsorption will be performed twice: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Baseline therapy | No intervention | Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoadsorption. |
| Basic therapy + Efferon LPS | Experimental | Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoadsorption with Efferon LPS. Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOFA
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
Measured: 1-7 days
Secondary outcomes (6)
Vasopressor free days
- Vasopressor free days = 0 if subject dies within 28 days of starting vasopressor support.
- Vasopressor free days = 28 - x if vasopressor support is successfully discontinued x days after initiation.
- Vasopressor free days = 0 if the subject requires vasopressor support for more than 28 days.
Measured: 1-28 days
Renal replacement therapy (RRT) duration
- 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
Mechanical ventilation duration
Ventilator-free days = 0 if subject dies within 28 days of mechanical ventilation.
Ventilator-free days = 28 - x if successfully liberated from ventilation x days after initiation.
Ventilator-free days = 0 if the subject is mechanically ventilated for >28 days.
Measured: 1-28 days
Length of stay in the intensive care unit
Time (number of days) from surgery to transfer from the intensive care unit within 60 days
Measured: 1-28 days
28 days mortality
Mortality rate
Measured: 1-28 days
Incidence of postoperative complications
Incidence of postoperative complications, including sepsis, pneumonia, surgical site infections, stroke, bleeding events, and the need for mechanical ventilation, renal replacement therapy, and vasopressor support.
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 posted15 Apr 2026
- Study start22 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies 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
- Model description
- Participants will be randomized in a 1:1 ratio using stratified randomization based on preoperative risk assessed by EuroSCORE II, with two strata: high risk (EuroSCORE II 6-10%) and very high risk (\>10%).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuri Polushin, PhD, MD, Principal investigator, Pavlov First Saint Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532174
- Sponsor's protocol ID
- efferon-lps-2024-04.1
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2026
- Last updated
- 26 Aug 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Early Postoperative Use of Lipopolysaccharide Adsorption (Efferon LPS) in Cardiac Surgery Patients to Reduce the Incidence of Multiple Organ Dysfunction Syndrome in the Postoperative Period
- ClinicalTrials.gov ID
- NCT07532174
- Acronym / sponsor ID
- efferon-lps-2024-04.1
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 15 Apr 2026 (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 randomized controlled study aims to evaluate the efficacy and safety of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period. Each patient in the treatment group will undergo two hemoadsorption sessions: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours.
Detailed description
Annually, over 1 million people worldwide undergo cardiac surgery. Most cardiac procedures still require cardiopulmonary bypass (CPB), myocardial protection during aortic cross-clamping, and the induction of cardioplegic arrest by administering cardioplegic solutions into the coronary circulation. All of these factors contribute to ischemia-reperfusion injury of the myocardium, which remains a leading cause of acute heart failure following the restoration of spontaneous circulation and, consequently, the development of post-perfusion multiple organ dysfunction, particularly acute kidney injury (AKI).
AKI occurs in approximately 7% of all hospitalized patients, 30% of intensive care unit patients, and up to 30% of patients undergoing cardiac surgery. Endotoxemia is one of the major contributors to the development of AKI. Septic AKI, compared with non-septic AKI, is associated with poorer prognosis, longer hospital stays, and lower survival rates.
The goal of the study is to evaluate the safety and efficacy of intraoperative and early postoperative hemoadsorption using the Efferon® LPS device in patients undergoing cardiac surgery with cardiopulmonary bypass in reducing the incidence and severity of multiple organ dysfunction syndrome (MODS) in the postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio using stratified randomization based on preoperative risk assessed by EuroSCORE II, with two strata: high risk (EuroSCORE II 6-10%) and very high risk (>10%).
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy | No intervention | –Patients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass without hemoadsorption. |
| Basic therapy + Efferon LPS | Experimental | Device: Efferon LPSPatients will be treated according to the standard protocol for cardiac surgery with cardiopulmonary bypass and will receive hemoadsorption with Efferon LPS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB).
- EuroSCORE II ≥6%
Key exclusion criteria (5 listed)
- Procalcitonin ≥2 ng/mL
- Severe chronic liver disease, defined as Child-Pugh class C (>10 points) or clinically manifest hepatic failure
- Dialysis-dependent chronic kidney disease (CKD)
- Ongoing immunosuppressive therapy, including corticosteroids or cytotoxic agents, excluding standard perioperative medications
- Any other clinical condition that, in the investigator's opinion, would preclude the patient's participation in the study
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. Efferon LPS hemoadsorption will be performed twice: first during cardiopulmonary bypass (CPB) at the time of cardiac surgery, with the duration determined by the CPB time, and second within 24 hours postoperatively, for a minimum duration of 6 hours. | Device | Basic therapy + Efferon LPS |
Primary outcome
SOFA
Time frame: 1-7 days
The Sequential Organ Failure Assessment (SOFA) score is equal to the sum of six indicators. The higher the score, the greater the insufficiency of the system being assessed. The higher the overall score, the greater the degree of multiorgan dysfunction. Violation of the function of each organ (system) is assessed separately in dynamics against the background of intensive therapy. With a score of no more than 12, multiple organ dysfunctions are assumed, 13-17 points indicate the transition of dysfunction to insufficiency, a score of about 24 indicates a high probability of death. The lower the SOFA score, the less pronounced organ failure and the better the patient's survival prognosis.
6 secondary outcomes
Vasopressor free days
Time frame: 1-28 days
Renal replacement therapy (RRT) duration
Time frame: 1-28 days
Mechanical ventilation duration
Time frame: 1-28 days
Length of stay in the intensive care unit
Time frame: 1-28 days
28 days mortality
Time frame: 1-28 days
Incidence of postoperative complications
Time frame: 1-28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Cardiac Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
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.
Yuri Polushin, PhD, MD principal investigator
Pavlov First Saint Petersburg State Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon LPS in people with Cardiac Disease and Multiple Organ Dysfunction Syndrome, run by Efferon JSC at 3 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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandr Shelehov-Kravchenko, PhD, MD (+79636564765, ais@efferon.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOFA (time frame: 1-7 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 26 Aug 2026.