NCT07532174 Efferon LPS Hemoadsorption in Cardiac Surgery Patients
| NCT ID | NCT07532174 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Efferon JSC |
| Condition | Cardiac Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-04-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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
Contact & Investigator
Yuri Polushin, PhD, MD
PRINCIPAL INVESTIGATOR
Pavlov First Saint Petersburg State Medical University
Frequently Asked Questions
Who can join the NCT07532174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07532174 currently recruiting?
Yes, NCT07532174 is actively recruiting participants. Contact the research team at ais@efferon.ru for enrollment information.
Where is the NCT07532174 trial being conducted?
This trial is being conducted at Barnaul, Russia, Saint Petersburg, Russia, Saint Petersburg, Russia.
Who is sponsoring the NCT07532174 clinical trial?
NCT07532174 is sponsored by Efferon JSC. The principal investigator is Yuri Polushin, PhD, MD at Pavlov First Saint Petersburg State Medical University. The trial plans to enroll 60 participants.