Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34HL130738-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Food and Drug Administration (FDA) | FED |
| Physio-Control | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | 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 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Expedited Transport With Mechanical CPR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department Arrivals Under 30 Minutes | 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). | Measured within one hour cardiac arrest onset |
| ECPR Initiations Under 30 Minutes | Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival | Measured within 2 hours of cardiac arrest onset |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Functional Neurological Outcome: CPC | Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest |
| Functional Neurological Outcome: mRS |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert W Neumar, MD, PhD | University of Michigan | Principal Investigator |
| Robert H Bartlett, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33541748 | Derived | Hsu CH, Meurer WJ, Domeier R, Fowler J, Whitmore SP, Bassin BS, Gunnerson KJ, Haft JW, Lynch WR, Nallamothu BK, Havey RA, Kidwell KM, Stacey WC, Silbergleit R, Bartlett RH, Neumar RW. Extracorporeal Cardiopulmonary Resuscitation for Refractory Out-of-Hospital Cardiac Arrest (EROCA): Results of a Randomized Feasibility Trial of Expedited Out-of-Hospital Transport. Ann Emerg Med. 2021 Jul;78(1):92-101. doi: 10.1016/j.annemergmed.2020.11.011. Epub 2021 Feb 1. |
| Label | URL |
|---|---|
| EROCA Study Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Expedited Transport |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
modified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. |
| At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest |
| Neuropsychological Outcome Battery: NIH Toolbox | The NIH toolbox includes cognitive testing and can be administered using an iPad | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest |
| Neuro Quality of Life: Neuro QoL | Quality 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. | 90 days after cardiac arrest |
| Safety: Composite Prevalence of 6 Specified Adverse Events | Composite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection. | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest |
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.
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Initial cardiac rythm | Count of Participants | Participants |
| ||||||||||||||||
| Bystander CPR | Count of Participants | Participants |
| ||||||||||||||||
| Cardiac Arrest Locaion | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Emergency Department Arrivals Under 30 Minutes | 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). | Standard care participants received EMS protocols at the scene, and thus were not included in this analysis | Posted | Count of Participants | Participants | Measured within one hour cardiac arrest onset |
|
|
| |||||||||||||||||||||||||||||
| Primary | ECPR Initiations Under 30 Minutes | Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival | Analysis includes participants eligible for ECPR. | Posted | Count of Participants | Participants | Measured within 2 hours of cardiac arrest onset |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Neurological Outcome: CPC | Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome | Not Posted | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Functional Neurological Outcome: mRS | modified Rankin Score commonly used for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. | Not Posted | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Neuropsychological Outcome Battery: NIH Toolbox | The NIH toolbox includes cognitive testing and can be administered using an iPad | Not Posted | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Neuro Quality of Life: Neuro QoL | Quality 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. | Not Posted | 90 days after cardiac arrest | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | Safety: Composite Prevalence of 6 Specified Adverse Events | Composite safety endpoint of hemorrhage requiring blood transfusion, vessel damage requiring vascular procedure or leading to occlusion, venous/arterial thromboembolism, stroke, renal failure, and infection. | Not Posted | At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest | Participants |
Participants were followed for 90 days after intervention
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 2 | 3 | 2 | 3 | 0 | 3 |
| EG001 | 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. | 12 | 12 | 6 | 12 | 0 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage from cannulation site | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Acute Kidney Injury (AKI) | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hemorrhagic Shock | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hemoperitoneum | Nervous system disorders | Non-systematic Assessment |
| ||
| Anoxic brain injury | Nervous system disorders | Non-systematic Assessment |
| ||
| Failure to establish circuit blood flow | Cardiac disorders | Non-systematic Assessment |
| ||
| Ventricular Fibrillation/Ventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cardiogenic Shock | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute Liver Injury | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Ischemic Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Ischemic Skin Necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Presumed Moderate Acute Respiratory Distress Syndrome (ARDS) | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Non ST Elevation Myocardial Infarction (NSTEMI) | Cardiac disorders | Non-systematic Assessment |
| ||
| Tracheal aspirate - Methicillin-sensitive Staphylococcus aureus (MSSA) | Infections and infestations | Non-systematic Assessment |
| ||
| Hemopericardium | Cardiac disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Neumar | University of Michigan | 734-936-0253 | neumar@umich.edu |
| Nov 23, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D016757 | Death, Sudden, Cardiac |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Witnessed pulseless electrical activity (PEA) |
|
| Witnessed asystole |
|
| Public Location |
|
| Participants |
|
|