Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction
NCT06955936 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-06-05
Summary
Cardiogenic shock is the most severe manifestation of acute heart failure and remains the leading cause of death in patients hospitalised with acute myocardial infarction.
Cardiogenic shock is a well-known and potent trigger of the immune response, ischemia/reperfusion organ damage, hemolysis and release of free hemoglobin. The activation of immune cells leads to the release of cytokines and inflammatory mediators such as IL-6, IL-8, activated complement and others. As a result of myocardial ischaemia and reperfusion injury, a multiorgan dysfunction syndrome may develop.
The Efferon CT hemoadsorption device effectively removes cytokines and other pro-inflammatory molecules (≤55 kDa). This study evaluates whether this blood-filtering therapy can prevent organ failure in acute myocardial infarction patients with cardiogenic shock by eliminating inflammation-inducing mediators.
Conditions
- Myocardial Infarction
- Cardiogenic Shock
Interventions
- DEVICE
-
Efferon CT
Efferon CT (JSC Efferon, Moscow, RF) is a device for extracorporeal blood purification by direct hemoadsorption. Detoxification is carried out by sorption of cytokines and other products of endogenous intoxication with a molecular size of up to 55 kDa. The therapy will be performed once no later than 4 hours after the diagnosis of cardiogenic shock. The duration of hemoadsorption is from 4 to 12 hours. The rate of hemoadsorption is from 80 to 150 ml/min. Anticoagulation is systemic (heparin or sodium citrate).
Sponsors & Collaborators
-
Efferon JSC
lead INDUSTRY
Principal Investigators
-
Vyacheslav Ryabov, PhD, MD · Tomsk NRMC Cardiology Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-29
- Primary Completion
- 2027-04-29
- Completion
- 2027-07-31
Countries
- Russia
Study Locations
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