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Efferon LPS Hemoadsorption in Cardiac Surgery Patients

Sponsor: Efferon JSC • ClinicalTrials.gov ID: NCT07532174

Registry updated: 2026-08-26

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Description

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.

Interventions

Efferon LPS (Device)
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.

Eligibility criteria

Inclusion Criteria: * Adult patients undergoing elective or emergency cardiac surgery with the use of cardiopulmonary bypass (CPB). * EuroSCORE II ≥6% Exclusion Criteria: * 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

Conditions

Cardiac Disease Multiple Organ Dysfunction Syndrome

Locations

Regional State Budgetary Healthcare Institution "Altai Regional Cardiological Dispensary" — Barnaul, Russia
Almazov National Medical Research Centre — Saint Petersburg, Russia
Pavlov First Saint Petersburg State Medical University — Saint Petersburg, Russia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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