ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Condition: Cardiac Arrest; Heart Arrest; Sudden Cardiac Arrest; Cardiopulmonary Arrest; Death, Sudden, Cardiac; Cardiopulmonary Resuscitation; CPR; Extracorporeal Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Death, Sudden, Cardiac; Death, Sudden
Study type: Interventional

Summary: 
      In the U.S. alone, over 300,000 people per year have sudden out-of-hospital cardiac arrest
      (OHCA), and less than 1 out of 10 survive. The current standard practice for treating OHCA is
      to perform cardiopulmonary resuscitation (CPR) and Advanced Cardiovascular Life Support
      (ACLS) at the scene until either the heart is restarted or resuscitation efforts are
      considered hopeless and discontinued. An alternative strategy for those with refractory OHCA
      is expedited transport with ongoing mechanical CPR to an Emergency Department capable of
      performing extracorporeal cardiopulmonary resuscitation (ECPR). The purpose of study is to
      test if this strategy is feasible and beneficial.
    

Detailed description: 
      Out-of-hospital sudden cardiac arrest (OHCA) is a life-threatening condition in which the
      heart suddenly stops beating and there is no blood flow to the body. If cardiac arrest is not
      treated immediately, it causes sudden death. In the U.S. alone, over 300,000 people per year
      have OHCA, and less than 1 out of 10 survive. Therefore, it is important to study new ways of
      treating cardiac arrest patients in order to improve survival.

      The current standard practice for treating OHCA is to perform CPR and Advanced Cardiovascular
      Life Support (ACLS) at the scene until either the heart is restarted or resuscitation efforts
      are considered hopeless and discontinued. This practice is supported by the fact that all
      currently proven CPR therapies can be delivered by paramedics in the field.

      However, promising new strategies have emerged that are more feasible to initiate in the
      hospital. One such strategy is extracorporeal cardiopulmonary resuscitation (ECPR). ECPR
      requires placement of catheters in large blood vessels and connected to a machine to take
      over the work of the heart and lungs.

      This purpose of this study is to examine the feasibility and potential benefit of expedited
      transport with ongoing mechanical CPR for patients with refractory OHCA patients to an
      Emergency Department capable of initiating ECPR.

      FDA approved this study as a staged feasibility study to enroll 15 participants and submit
      data prior to enrolling the second 15 participants. After enrolling 15 participants, the PI
      chose not to pursue an amendment to enroll additional participants due to slow accrual and
      research restrictions related to COVID.
    

Intervention name(s): Expedited Transport With Mechanical CPR
Intervention type(s): Device
Intervention description(s): Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Out-of-hospital cardiac arrest; Cardiac Arrest; Heart Arrest; Sudden Cardiac Arrest; Cardiopulmonary Resuscitation; Extracorporeal Cardiopulmonary Resuscitation; Extracorporeal Membrane Oxygenation; CPR; ECPR; ECMO; Emergency Medical Services; EMS; OHCA