NCT03065647: EROCA

ECPR for Refractory Out-Of-Hospital Cardiac Arrest

Completed NA Results posted Last updated 3 June 2021

What this trial tests

NA trial testing Expedited Transport With Mechanical CPR in Cardiac Arrest in 15 participants. Completed in 5 March 2020.

Timeline

1 May 2017

Primary endpoint
5 March 2020

5 March 2020

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 May 2017
Primary completion	5 March 2020
Estimated completion	5 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Expedited Transport With Mechanical CPR

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →
• Heart Arrest — all drugs for Heart Arrest →
• Sudden Cardiac Arrest — all drugs for Sudden Cardiac Arrest →
• Cardiopulmonary Arrest — all drugs for Cardiopulmonary Arrest →

Sponsor

University of Michigan

Who can join

Adults 18 to 70, any sex, with Cardiac Arrest or Heart Arrest. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Emergency Department Arrivals Under 30 Minutes Primary · Measured within one hour cardiac arrest onset

Proportion of patients with emergency department (ED) arrival less than or equal to 30 minutes from 911 call (or cardiac arrest onset if witnessed by EMS personnel).

Group	Value	95% CI
Expedited Transport	5

ECPR Initiations Under 30 Minutes Primary · Measured within 2 hours of cardiac arrest onset

Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival

Group	Value	95% CI
Expedited Transport	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were followed for 90 days after intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Care

Serious: 2/3 (67%)

Deaths: 2/3

Expedited Transport

Serious: 6/12 (50%)

Deaths: 12/12

Serious adverse events (17 terms)

Reaction	System	Standard Care	Expedited Transport
Acute Kidney Injury (AKI)	Renal and urinary disorders	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—
Anoxic brain injury	Nervous system disorders	—	—
Cardiogenic Shock	Cardiac disorders	—	—
Hemorrhage from cannulation site	Surgical and medical procedures	—	—
Hemorrhagic Shock	Blood and lymphatic system disorders	—	—
Hemoperitoneum	Nervous system disorders	—	—
Failure to establish circuit blood flow	Cardiac disorders	—	—
Ventricular Fibrillation/Ventricular Tachycardia	Cardiac disorders	—	—
Gastrointestinal Hemorrhage	Gastrointestinal disorders	—	—
Acute Liver Injury	Hepatobiliary disorders	—	—
Ischemic Stroke	Nervous system disorders	—	—
Ischemic Skin Necrosis	Skin and subcutaneous tissue disorders	—	—
Presumed Moderate Acute Respiratory Distress Syndrome (ARDS)	Reproductive system and breast disorders	—	—
Non ST Elevation Myocardial Infarction (NSTEMI)	Cardiac disorders	—	—
Tracheal aspirate - Methicillin-sensitive Staphylococcus aureus (MSSA)	Infections and infestations	—	—
Hemopericardium	Cardiac disorders	—	—

Most-reported serious reactions: Acute Kidney Injury (AKI), Pneumonia, Anoxic brain injury, Cardiogenic Shock, Hemorrhage from cannulation site, Hemorrhagic Shock, Hemoperitoneum, Failure to establish circuit blood flow.

Data from ClinicalTrials.gov NCT03065647 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extracorporeal cardiopulmonary resuscitation for cardiac arrest: A systematic review.
   Holmberg MJ, Geri G, Wiberg S, Guerguerian AM, et al · · 2018 · cited 179× · PMID 30063963 · DOI 10.1016/j.resuscitation.2018.07.029
2. Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest in Adult Patients.
   Inoue A, Hifumi T, Sakamoto T, Kuroda Y. · · 2020 · cited 129× · PMID 32204668 · DOI 10.1161/jaha.119.015291
3. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport.
   Hsu CH, Meurer WJ, Domeier R, Fowler J, et al · · 2021 · cited 85× · PMID 33541748 · DOI 10.1016/j.annemergmed.2020.11.011
4. A systematic review of current ECPR protocols. A step towards standardisation.
   Koen 'J, Nathanaël T, Philippe D. · · 2020 · cited 44× · PMID 34223301 · DOI 10.1016/j.resplu.2020.100018
5. Pre-hospital extra-corporeal cardiopulmonary resuscitation.
   Singer B, Reynolds JC, Lockey DJ, O'Brien B. · · 2018 · cited 40× · PMID 29587810 · DOI 10.1186/s13049-018-0489-y
6. The Association of Modifiable Postresuscitation Management and Annual Case Volume With Survival After Extracorporeal Cardiopulmonary Resuscitation.
   Tonna JE, Selzman CH, Bartos JA, Presson AP, et al · · 2022 · cited 36× · PMID 35923595 · DOI 10.1097/cce.0000000000000733
7. Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 ​min in patients with refractory out-of-hospital cardiac arrest.
   Singer B, Reynolds JC, Davies GE, Wrigley F, et al · · 2020 · cited 28× · PMID 33403364 · DOI 10.1016/j.resplu.2020.100029
8. ECPR for out-of-hospital cardiac arrest: more evidence is needed.
   MacLaren G, Masoumi A, Brodie D. · · 2020 · cited 28× · PMID 31910905 · DOI 10.1186/s13054-019-2722-0