RecruitingNot ApplicableNCT06955936

Efferon CT Hemoadsorption for Cardiogenic Shock in Acute Myocardial Infarction

An Open Randomized Study on the Efficacy and Safety of Hemoadsorption With Efferon CT in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction


Sponsor

Efferon JSC

Enrollment

60 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria13

  • 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

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Interventions

DEVICEEfferon 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).


Locations(1)

Tomsk NRMC Cardiology Research Institute

Tomsk, Russia

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NCT06955936


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