ARREST: Advanced Reperfusion Strategies for Refractory Cardiac Arrest

• Sponsor: University of Minnesota (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03880565
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
• Actual Study Start Date: Aug 9, 2019
• Actual Primary Completion Date: Oct 9, 2020
• Actual Study Completion Date: Oct 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ECMO Facilitated Resuscitation Regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, patients will enter the Cardiac Catheterization Laboratory (CCL) for expeditious VAECMO initiation, 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
Other: Standard 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

Outcome Measures

Primary Outcome Measures

1. Survival [Approximately 25 days]

   Number of participants who survived to hospital discharge

Secondary Outcome Measures

1. Modified Rankin Scale (mRS) Score [At hospital discharge (average of 25 days), 3 months, 6 months]

   mRS scale ranges from 0 (no residual symptoms) to 6 (dead). 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. Higher scores on the scale indicate more severe disability. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.

2. Cerebral Performance Categories (CPC) Scale [At hospital discharge (average of 25 days), 3 months, 6 months]

   CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status. Higher scores on the scale indicate worse cerebral performance. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.

3. Treatment Cost [6 months]

   Outcome is reported as the mean treatment cost in dollars.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adults (presumed or known to be aged 18-75 years, inclusive),

• An initial documented OHCA rhythm of VF/VT,

• No ROSC following 3 defibrillation shocks,

• Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and

• Estimated transfer time from the scene to the ED or CCL of < 30 minutes.

Exclusion Criteria:

• Age < 18 years old or > 75 years old;

• Non-shockable initial OHCA rhythm (pulseless electrical activity [PEA] or asystole);

• Valid do-not-attempt-resuscitation orders (DNAR);

• Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose;

• Known prisoners;

• Known pregnancy;

• Nursing home residents;

• Unavailability of the cardiac catheterization laboratory.

• Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure;

• Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

• Principal Investigator: Demetris Yannopoulos, MD, University of Minnesota
• Study Chair: Tom Aufderheide, MD, University of Minnesota

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 10, 2020
• Informed Consent Form - Jan 14, 2020

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03880565
• Other Study ID Numbers: CV-2018-27226
• First Posted: Mar 19, 2019
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of Minnesota: advanced reperfusion; mechanical cardiopulmonary resuscitation
• Additional relevant MeSH terms: Heart Arrest; Tachycardia; Tachycardia, Ventricular; Out-of-Hospital Cardiac Arrest; Ventricular Fibrillation

Study Results

Participant Flow

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	15
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation	Total
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation	Total of all reporting groups
Overall Participants	15	15	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 66.7%	11 73.3%	21 70%
>=65 years	5 33.3%	4 26.7%	9 30%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.8 (9.7)	57.1 (10.6)	58.5 (10)
Sex: Female, Male (Count of Participants)
Female	1 6.7%	4 26.7%	5 16.7%
Male	14 93.3%	11 73.3%	25 83.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 6.7%	0 0%	1 3.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 6.7%	1 6.7%	2 6.7%
White	6 40%	2 13.3%	8 26.7%
More than one race	1 6.7%	0 0%	1 3.3%
Unknown or Not Reported	6 40%	12 80%	18 60%
Region of Enrollment (participants) [Number]
United States	15 100%	15 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Survival
Description	Number of participants who survived to hospital discharge
Time Frame	Approximately 25 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
Measure Participants	15	15
Count of Participants [Participants]	6 40%	1 6.7%

2. Secondary Outcome

Title	Modified Rankin Scale (mRS) Score
Description	mRS scale ranges from 0 (no residual symptoms) to 6 (dead). 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. Higher scores on the scale indicate more severe disability. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Time Frame	At hospital discharge (average of 25 days), 3 months, 6 months

Outcome Measure Data

Analysis Population Description

All participants who completed each time point are included.

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
Measure Participants	15	15
Hospital Discharge	3.8	5
Three Months	2
Six Months	1.5

3. Secondary Outcome

Title	Cerebral Performance Categories (CPC) Scale
Description	CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status. Higher scores on the scale indicate worse cerebral performance. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Time Frame	At hospital discharge (average of 25 days), 3 months, 6 months

Outcome Measure Data

Analysis Population Description

All participants who completed each time point are included.

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
Measure Participants	15	15
Hospital Discharge	2.5	4
Three Months	1.2
Six Months	1.2

4. Secondary Outcome

Title	Treatment Cost
Description	Outcome is reported as the mean treatment cost in dollars.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Outcome was not collected.

Arm/Group Title	ECMO Facilitated Resuscitation	Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO	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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
Measure Participants	0	0

Adverse Events

Time Frame	Six months following hospital discharge
Arm/Group Title	ECMO Facilitated Resuscitation		Standard ACLS Resuscitation
Arm/Group Description	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. Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation: Early use of ECMO		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. Standard Advanced Cardiac Life Support (ACLS) Resuscitation: Standard life support resuscitation
All Cause Mortality
	ECMO Facilitated Resuscitation		Standard ACLS Resuscitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/15 (60%)		14/15 (93.3%)
Serious Adverse Events
	ECMO Facilitated Resuscitation		Standard ACLS Resuscitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/15 (100%)		15/15 (100%)
Blood and lymphatic system disorders
Bleeding	7/15 (46.7%)	7	0/15 (0%)	0
Circulatory Disorder	15/15 (100%)	45	15/15 (100%)	20
Endocrine disorders
Endocrine Disorders	13/15 (86.7%)	20	10/15 (66.7%)	12
Gastrointestinal disorders
Gastrointestinal Disorder	9/15 (60%)	10	2/15 (13.3%)	2
General disorders
Other Disorder	9/15 (60%)	13	2/15 (13.3%)	3
Infections and infestations
Infection	5/15 (33.3%)	6	0/15 (0%)	0
Injury, poisoning and procedural complications
CPR Trauma	11/15 (73.3%)	198	1/15 (6.7%)	2
Nervous system disorders
Central Nervous System Disorders	9/15 (60%)	12	1/15 (6.7%)	3
Renal and urinary disorders
Kidney Disorders	10/15 (66.7%)	18	1/15 (6.7%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder	13/15 (86.7%)	19	2/15 (13.3%)	4
Other (Not Including Serious) Adverse Events
	ECMO Facilitated Resuscitation		Standard ACLS Resuscitation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.