Advanced Reperfusion Strategies for Refractory Cardiac Arrest (ARREST)
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|ClinicalTrials.gov Identifier: NCT03880565|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : August 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest Extracorporeal Membrane Oxygenation Complication Ventricular Fibrillation Pulseless Ventricular Tachycardia Out-Of-Hospital Cardiac Arrest||Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)|
|Actual Study Start Date :||August 9, 2019|
|Actual Primary Completion Date :||June 9, 2020|
|Estimated Study Completion Date :||January 5, 2021|
Experimental: ECMO Facilitated Resuscitation
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: ECMO is initiated expeditiously, regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate.
Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
Early use of ECMO
Standard ACLS Resuscitation
Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI and potential VA ECMO or other circulatory support device initiation, as clinically indicated.
Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Standard life support resuscitation
- Survival [ Time Frame: 1 week ]Survival to hospital discharge.
- Survival to hospital discharge with modified Rankin Scale Score (mRS) ≤ 3 along with functional status (Cerebral Performance Category [CPC]) [ Time Frame: 1 week, 3 months, 6 months ]Survival to hospital discharge with mRS ≤ 3 along with functional status as measured by CPC. mRS scale ranges from 0 (no residual symptoms) to 6 (dead) with 7 (unable to contact patient/caregiver) and 8 (mRS not performed). Scores of 3 (the patient has moderate disability), 2 (the patient has slight disability), 1 (the patient has no significant disability), and 0 indicate favorable outcome. CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status.
- Treatment cost [ Time Frame: 6 months ]Cost per patient and cost per life saved
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880565
|United States, Minnesota|
|University of Minnesota Medical Center, Fairview|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Demetris Yannopoulos, MD||University of Minnesota|
|Study Chair:||Tom Aufderheide, MD||University of Minnesota|