An interventional study of Expedited Transport With Mechanical CPR in Cardiac Arrest, Heart Arrest and Sudden Cardiac Arrest, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
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).
Device: 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
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).
Time frame: 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
Time frame: Measured within 2 hours of cardiac arrest onset
Functional Neurological Outcome: CPC
Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
| Milestone | Standard Care | Expedited Transport |
|---|---|---|
| Started | 3 | 12 |
| Completed | 3 | 12 |
| Not completed | 0 | 0 |
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).
| Participants | Standard Care | Expedited Transport |
|---|---|---|
| Emergency Department Arrivals Under 30 Minutes | — | 5 |
Proportion of ECPR eligible patients with ECPR flow initiated less than or equal to 30 minutes from ED arrival
| Participants | Standard Care | Expedited Transport |
|---|---|---|
| ECPR Initiations Under 30 Minutes | — | 3 |
Cerebral Performance Category score is widely used in cardiac arrest research to assess neurologic outcome
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
The NIH toolbox includes cognitive testing and can be administered using an iPad
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Participants were followed for 90 days after intervention. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | 2/3 (66.7%) | 2/3 (66.7%) | 0/3 (0%) |
| Expedited Transport | 12/12 (100%) | 6/12 (50%) | 0/12 (0%) |
| Event | Standard Care | Expedited Transport |
|---|---|---|
| Anoxic brain injuryNervous system disorders | 2/3 | 2/12 |
| Acute Kidney Injury (AKI)Renal and urinary disorders | 1/3 | 3/12 |
| Tracheal aspirate - Methicillin-sensitive Staphylococcus aureus (MSSA)Infections and infestations | 1/3 | 0/12 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/3 | 2/12 |
| Cardiogenic ShockCardiac disorders | 0/3 | 2/12 |
| Hemorrhage from cannulation siteSurgical and medical procedures | 0/3 | 1/12 |
| Hemorrhagic ShockBlood and lymphatic system disorders | 0/3 | 1/12 |
| HemoperitoneumNervous system disorders | 0/3 | 1/12 |
| Failure to establish circuit blood flowCardiac disorders | 0/3 | 1/12 |
| Ventricular Fibrillation/Ventricular TachycardiaCardiac disorders | 0/3 | 1/12 |
| Age, Continuous(years) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Mean | 61 ± 3 | 62 ± 8 | 62 ± 7 |
| Sex: Female, Male(Participants) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Female | 1 | 4 | 5 |
| Male | 2 | 8 | 10 |
| Race (NIH/OMB)(Participants) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 3 | 9 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 2 | 2 |
| Initial cardiac rythm(Participants) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Ventricular fibrilation | 3 | 5 | 8 |
| Witnessed pulseless electrical activity (PEA) | 0 | 4 | 4 |
| Witnessed asystole | 0 | 3 | 3 |
| Bystander CPR(Participants) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Count of participants | 3 | 10 | 13 |
| Cardiac Arrest Locaion(participants) | Standard Care | Expedited Transport | Total |
|---|---|---|---|
| Home | 2 | 10 | 12 |
| Public Location | 1 | 2 | 3 |
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