Early Initiation of Extracorporeal Life Support in Refractory OHCA
Condition: Cardiac Arrest; Out-Of-Hospital Cardiac Arrest; Sudden Cardiac Death
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac; Death
Study type: Interventional

Summary: 
      Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted
      defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained
      return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized
      controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in
      patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular
      fibrillation or tachycardia. It aims to determine the effect on survival and neurological
      outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.
    

Detailed description: 
      There are approximately 275,000 cases of out-of-hospital cardiac arrest (OHCA) per year in
      Europe, of which two-thirds have a primary cardiac origin. However, despite adequate
      conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a
      considerable number of these patients fail to achieve sustained return of spontaneous
      circulation (ROSC).

      Treatment of the underlying cause of the arrest, in most cases coronary artery occlusion, is
      paramount. But in the absence of ROSC, the possibilities to perform these life-saving
      interventions are limited. Continued CCPR is currently the standard of care for these
      patients. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) restores
      circulation, with the potential to minimize (or even reversing) organ damage, prevent
      re-arrest due to ischemia-triggered myocardial dysfunction and providing a bridge to possible
      diagnosis and treatment. Several studies have demonstrated that ECPR is feasible and may be
      advantageous with respect to survival and neurological outcome.

      The INCEPTION trial aims to compare ECPR to CCPR in the population that is expected to
      benefit the most from this intervention: young patients presenting with ventricular
      fibrillation or tachycardia (VF/VT) and a refractory cardiac arrest. Furthermore, it will
      provide data on the cost-effectiveness of this intervention, which to date has been
      unavailable. Although the costs may prove to be high, the gain in quality-adjusted life years
      (QALY's) may be substantial given the fact that most patients are relatively young and the
      current alternative carries a poor prognosis. This can determine whether ECPR should be
      pursued as a standard of care in patients with refractory arrest.
    

Intervention name(s): Extracorporeal cardiopulmonary resuscitation (ECPR)
Intervention type(s): Procedure
Intervention description(s): In addition to the routine response team, the ECLS team are called to the ED while the patient is transported to the hospital.
The team consists of a physician skilled and qualified in femoral cannulation, a perfusionist and a scrub nurse.
Upon the patient's arrival at the emergency department, CPR will be continued, with continuation of mechanical chest compressions with minimization of interruptions.
Time from arrest to start of cannulation is < 60 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ECPR; Extracorporeal CardioPulmonary Resuscitation; OHCA; Out-of-Hospital Cardiac Arrest; CPR; CardioPulmonary Resuscitation; ECMO; ExtraCorporeal Membrane Oxygenation; Refractory Cardiac Arrest