NCT03880565: ARREST

Advanced Reperfusion Strategies for Refractory Cardiac Arrest

Terminated NA Results posted Last updated 10 March 2022

What this trial tests

NA trial testing Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation in Cardiac Arrest in 30 participants. Terminated before completion.

Timeline

9 August 2019

Primary endpoint
9 October 2020

9 October 2020

Quick facts

Lead sponsor	University of Minnesota
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	9 August 2019
Primary completion	9 October 2020
Estimated completion	9 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation
• Standard Advanced Cardiac Life Support (ACLS) Resuscitation

Conditions studied

• Cardiac Arrest — all drugs for Cardiac Arrest →
• Extracorporeal Membrane Oxygenation Complication — all drugs for Extracorporeal Membrane Oxygenation Complication →
• Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
• Pulseless Ventricular Tachycardia — all drugs for Pulseless Ventricular Tachycardia →

Sponsor

University of Minnesota

Who can join

Adults 18 to 75, any sex, with Cardiac Arrest or Extracorporeal Membrane Oxygenation Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Survival Primary · Approximately 25 days

Number of participants who survived to hospital discharge

Group	Value	95% CI
ECMO Facilitated Resuscitation	6
Standard ACLS Resuscitation	1

Modified Rankin Scale (mRS) Score Secondary · 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.

Hospital Discharge

Group	Value	95% CI
ECMO Facilitated Resuscitation	3.8	3 – 4.6
Standard ACLS Resuscitation	5	NA – NA

Three Months

Group	Value	95% CI
ECMO Facilitated Resuscitation	2	.9 – 3.4

Six Months

Group	Value	95% CI
ECMO Facilitated Resuscitation	1.5	.4 – 2.6

Cerebral Performance Categories (CPC) Scale Secondary · 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.

Hospital Discharge

Group	Value	95% CI
ECMO Facilitated Resuscitation	2.5	1.9 – 3.1
Standard ACLS Resuscitation	4	NA – NA

Three Months

Group	Value	95% CI
ECMO Facilitated Resuscitation	1.2	.7 – 1.6

Six Months

Group	Value	95% CI
ECMO Facilitated Resuscitation	1.2	.7 – 1.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Six months following hospital discharge. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

ECMO Facilitated Resuscitation

Serious: 15/15 (100%)

Deaths: 9/15

Standard ACLS Resuscitation

Serious: 15/15 (100%)

Deaths: 14/15

Serious adverse events (10 terms)

Reaction	System	ECMO Facilitated Resuscita…	Standard ACLS Resuscitation
Circulatory Disorder	Blood and lymphatic system disorders	—	—
Endocrine Disorders	Endocrine disorders	—	—
Respiratory Disorder	Respiratory, thoracic and mediastinal disorders	—	—
CPR Trauma	Injury, poisoning and procedural complications	—	—
Kidney Disorders	Renal and urinary disorders	—	—
Central Nervous System Disorders	Nervous system disorders	—	—
Gastrointestinal Disorder	Gastrointestinal disorders	—	—
Other Disorder	General disorders	—	—
Bleeding	Blood and lymphatic system disorders	—	—
Infection	Infections and infestations	—	—

Most-reported serious reactions: Circulatory Disorder, Endocrine Disorders, Respiratory Disorder, CPR Trauma, Kidney Disorders, Central Nervous System Disorders, Gastrointestinal Disorder, Other Disorder.

Data from ClinicalTrials.gov NCT03880565 adverse events section.

Sponsor's own description

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

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial.
   Yannopoulos D, Bartos J, Raveendran G, Walser E, et al · · 2020 · cited 736× · PMID 33197396 · DOI 10.1016/s0140-6736(20)32338-2
2. Intraarrest transport, extracorporeal cardiopulmonary resuscitation, and early invasive management in refractory out-of-hospital cardiac arrest: an individual patient data pooled analysis of two randomised trials.
   Belohlavek J, Yannopoulos D, Smalcova J, Rob D, et al · · 2023 · cited 62× · PMID 37197707 · DOI 10.1016/j.eclinm.2023.101988
3. Sub30: Protocol for the Sub30 feasibility study of a pre-hospital Extracorporeal membrane oxygenation (ECMO) capable advanced resuscitation team at achieving blood flow within 30 ​min in patients with refractory out-of-hospital cardiac arrest.
   Singer B, Reynolds JC, Davies GE, Wrigley F, et al · · 2020 · cited 28× · PMID 33403364 · DOI 10.1016/j.resplu.2020.100029
4. Role of extracorporeal cardiopulmonary resuscitation in adults.
   Kim H, Cho YH. · · 2020 · cited 25× · PMID 32131575 · DOI 10.4266/acc.2020.00080
5. Extracorporeal cardiopulmonary resuscitation for in- and out-of-hospital cardiac arrest: systematic review and meta-analysis of propensity score-matched cohort studies.
   Miraglia D, Miguel LA, Alonso W. · · 2020 · cited 23× · PMID 33000057 · DOI 10.1002/emp2.12091
6. Oligometastatic Head and Neck Cancer: Challenges and Perspectives.
   Bahig H, Huang SH, O'Sullivan B. · · 2022 · cited 19× · PMID 36010888 · DOI 10.3390/cancers14163894
7. Extracorporeal cardiopulmonary resuscitation for refractory cardiac arrest: a scoping review.
   Miraglia D, Almanzar C, Rivera E, Alonso W. · · 2021 · cited 5× · PMID 33615309 · DOI 10.1002/emp2.12380