Efferon CT hemoadsorption for cardiogenic shock after a heart attack
An Open Randomized Study on the Efficacy and Safety of Hemoadsorption With Efferon CT in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction
This trial will test whether using the Efferon CT blood‑filtering device in patients who develop cardiogenic shock within hours of a heart attack can lower harmful inflammation and help prevent organ failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Efferon JSC Industry-sponsored |
| Locations | 1 site (Tomsk) |
| Trial ID | NCT06955936 on ClinicalTrials.gov |
What this trial studies
This interventional study uses the Efferon CT hemoadsorption device to remove cytokines and other pro‑inflammatory molecules (≤55 kDa) from the blood of patients with cardiogenic shock complicating acute myocardial infarction. Treatment is started early (within 4 hours of shock diagnosis) in patients with SCAI stages B–C who can receive at least 4 hours of therapy, and outcomes such as organ dysfunction scores, inflammatory markers, hemodynamic stability, and short‑term survival will be tracked. The rationale builds on prior hemoadsorption work (for example CytoSorb) that showed reductions in IL‑6 and improved hemodynamics in acute cardiac settings. The trial is conducted at Tomsk NRMC Cardiology Research Institute and applies standard inclusion and exclusion criteria to limit confounding from non‑AMI causes of shock or very advanced comorbidity.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients with acute myocardial infarction who develop cardiogenic shock within 4 hours, meet SCAI stages B–C, have SOFA ≤12, and can tolerate at least 4 hours of hemoadsorption treatment.
Not a fit: Patients with non‑AMI causes of shock (e.g., takotsubo, postcardiotomy, myocarditis), recent MI within 4 weeks, severe comorbidity (Charlson >9), end‑stage dialysis dependence, or on active immunosuppression are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the device could reduce systemic inflammation in cardiogenic shock and lower the risk of multiorgan failure and early death.
How similar studies have performed: Previous studies with the similar CytoSorb hemoadsorption device reported reductions in IL‑6 and lactate, improved hemodynamics, and signals of lower short‑term ICU mortality, but evidence remains limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Not more than 4 hours after diagnosis Cardiogenic shock complicating acute myocardial infarction * Stages B - C of cardiogenic shock according to SCAI * Patient condition allows treatment with Efferon® CT device for at least 4 hours * SOFA score 12 or less Exclusion Criteria: * Broken-heart syndrome (takotsubo cardiomyopathy) * Postcardiotomy cardiogenic shock * Acute myocardial infarction within the last 4 weeks * Myocarditis * Cardiac trauma * Charlson comorbidity index greater than 9 points * Chronic kidney disease, stage 5 D (requiring continuous hemodialysis) * Acute pulmonary embolism * Acute cerebral circulatory collapse * Transfusion reaction * Patients on immunosuppressive therapy for cancer and autoimmune diseases * Pregnancy * Any other clinical condition of the patient that in the opinion of the investigator precludes inclusion in this study
Where this trial is running
Tomsk
- Tomsk NRMC Cardiology Research Institute — Tomsk, Russia (Recruiting)
Study contacts
- Principal investigator: Vyacheslav Ryabov, PhD, MD — Tomsk NRMC Cardiology Research Institute
- Study coordinator: Alexandr Shelehov-Kravchenko, PhD, MD
- Email: alexandr.shelehov@gmail.com
- Phone: +79636564765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.