Trial Outcomes & Findings for ECPR for Refractory Out-Of-Hospital Cardiac Arrest (NCT NCT03065647)
NCT ID: NCT03065647
Last Updated: 2021-06-03
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Measured within one hour cardiac arrest onset
Results posted on
2021-06-03
Participant Flow
Participant milestones
| Measure |
Standard Care
Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
|
Expedited Transport
Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
12
|
|
Overall Study
COMPLETED
|
3
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ECPR for Refractory Out-Of-Hospital Cardiac Arrest
Baseline characteristics by cohort
| Measure |
Standard Care
n=3 Participants
Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
|
Expedited Transport
n=12 Participants
Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: 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.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 3 • n=5 Participants
|
62 years
STANDARD_DEVIATION 8 • n=7 Participants
|
62 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Initial cardiac rythm
Ventricular fibrilation
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Initial cardiac rythm
Witnessed pulseless electrical activity (PEA)
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Initial cardiac rythm
Witnessed asystole
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Bystander CPR
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cardiac Arrest Locaion
Home
|
2 participants
n=5 Participants
|
10 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Cardiac Arrest Locaion
Public Location
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured within one hour cardiac arrest onsetPopulation: Standard care participants received EMS protocols at the scene, and thus were not included in this analysis
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).
Outcome measures
| Measure |
Standard Care
Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
|
Expedited Transport
n=12 Participants
Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: 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.
|
|---|---|---|
|
Emergency Department Arrivals Under 30 Minutes
|
—
|
5 Participants
|
PRIMARY outcome
Timeframe: Measured within 2 hours of cardiac arrest onsetPopulation: Analysis includes participants eligible for ECPR.
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
Outcome measures
| Measure |
Standard Care
Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
|
Expedited Transport
n=5 Participants
Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: 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.
|
|---|---|---|
|
ECPR Initiations Under 30 Minutes
|
—
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrestCerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrestmodified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrestThe NIH toolbox includes cognitive testing and can be administered using an iPad
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days after cardiac arrestQuality of Life in Neurological Disorders is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults living with neurological conditions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrestComposite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection.
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths
Expedited Transport
Serious events: 6 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Standard Care
n=3 participants at risk
Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols at the scene of the cardiac arrest.
|
Expedited Transport
n=12 participants at risk
Intervention: Expedited Transport with Mechanical CPR.
After initial Basic Life Support (BLS) and Advanced Cardiovascular Life Support (ACLS) by Emergency Medical Services (EMS) per existing EMS protocols, patients with refractory cardiac arrest are transported to an ECPR capable emergency department with ongoing mechanical CPR and ACLS for possible initiation of extracorporeal cardiopulmonary resuscitation (ECPR).
Expedited Transport With Mechanical CPR: 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.
|
|---|---|---|
|
Surgical and medical procedures
Hemorrhage from cannulation site
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
16.7%
2/12 • Participants were followed for 90 days after intervention
|
|
Renal and urinary disorders
Acute Kidney Injury (AKI)
|
33.3%
1/3 • Participants were followed for 90 days after intervention
|
25.0%
3/12 • Participants were followed for 90 days after intervention
|
|
Blood and lymphatic system disorders
Hemorrhagic Shock
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Nervous system disorders
Hemoperitoneum
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Nervous system disorders
Anoxic brain injury
|
66.7%
2/3 • Participants were followed for 90 days after intervention
|
16.7%
2/12 • Participants were followed for 90 days after intervention
|
|
Cardiac disorders
Failure to establish circuit blood flow
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Cardiac disorders
Ventricular Fibrillation/Ventricular Tachycardia
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
16.7%
2/12 • Participants were followed for 90 days after intervention
|
|
Hepatobiliary disorders
Acute Liver Injury
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Nervous system disorders
Ischemic Stroke
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Skin and subcutaneous tissue disorders
Ischemic Skin Necrosis
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Reproductive system and breast disorders
Presumed Moderate Acute Respiratory Distress Syndrome (ARDS)
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Cardiac disorders
Non ST Elevation Myocardial Infarction (NSTEMI)
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
|
Infections and infestations
Tracheal aspirate - Methicillin-sensitive Staphylococcus aureus (MSSA)
|
33.3%
1/3 • Participants were followed for 90 days after intervention
|
0.00%
0/12 • Participants were followed for 90 days after intervention
|
|
Cardiac disorders
Hemopericardium
|
0.00%
0/3 • Participants were followed for 90 days after intervention
|
8.3%
1/12 • Participants were followed for 90 days after intervention
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place