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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03065647
Other study ID # HUM00117553
Secondary ID R34HL130738-01A1
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date March 5, 2020

Study information

Verified date May 2021
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 5, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Michigan Hospital Ann Arbor Michigan

Sponsors (4)

Lead Sponsor Collaborator
University of Michigan Food and Drug Administration (FDA), National Heart, Lung, and Blood Institute (NHLBI), Physio-Control

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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. At time of hospital discharge (an average of 7 days) and 90 days after cardiac arrest
Other 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
Other 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
Other 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
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). 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 Measured within 2 hours of cardiac arrest onset
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