N/A
N=15
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Cardiac Arrest · Heart Arrest · Sudden Cardiac Arrest · Cardiopulmonary Arrest · Death, Sudden, Cardiac
Bottom Line
View on ClinicalTrials.gov: NCT03065647 ↗Enrolled (actual)
15
Serious AEs
53.3%
Results posted
Mar 2021
Primary outcome: Primary: Emergency Department Arrivals Under 30 Minutes — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Expedited Transport With Mechanical CPR (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emergency Department Arrivals Under 30 Minutes |
5 | — |
| PRIMARY ECPR Initiations Under 30 Minutes |
3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- OHCA of presumed non-traumatic etiology requiring CPR
- Predicted arrival time at ECPR-capable hospital within timeframe specified
- Witnessed arrest or initial shockable rhythm (VT or VF)
- Persistent cardiac arrest after initial cardiac rhythm analysis and shock (if shock is indicated)
Exclusion Criteria
- Sustained return of spontaneous circulation (ROSC)
- Advanced directive indicating do not attempt resuscitation (DNAR) or do not intubate (DNI)
- Preexisting evidence of opting out of study
- Prisoner
- Pregnant (obvious or known)
- ECPR capable ED is not at the destination hospital as determined by EMS
- Legally authorized representative (LAR) or family member aware of study and refuses study participation at the scene
Data sourced from ClinicalTrials.gov (NCT03065647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.