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A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest (ARREST)

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ClinicalTrials.gov Identifier: NCT03872960
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
King's College London
London School of Hygiene and Tropical Medicine
Barts & The London NHS Trust
King's College Hospital NHS Trust
Imperial College Healthcare NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
London Ambulance Service
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
The aim of ARREST is to determine the best post-resuscitation care pathway for out of hospital cardiac arrest patients without ST-segment elevation. The investigators propose that changes to emergency management comprising expedited delivery to a specialist heart attack centre with organised post-cardiac arrest care including immediate access to reperfusion therapy will reduce mortality in patients without STE compared to the current standard of care, which comprises protracted pre-hospital management of the patient without definitive care plan and delivery to geographically closest hospital.

Condition or disease Intervention/treatment Phase
Out-Of-Hospital Cardiac Arrest Procedure: Transfer to cardiac arrest centre Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Expedited Transfer to a Cardiac Arrest Centre for Non-ST Elevation Out-of-hospital Cardiac Arrest
Actual Study Start Date : February 2, 2018
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : April 20, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm: Expedited transfer to a CAC
The intervention arm consists of activation of the pre-hospital triaging system currently in place for post-arrest STE patients. This involves pre-alert of the CAC and strategic delivery of the patient to the catheter laboratory (24 hours a day, 7 days a week). Patients will receive definitive post-resuscitation care: intubation and ventilation, where necessary, targeted temperature management, and goal directed therapies including evaluation and identification of underlying cause of arrest with access to immediate reperfusion if necessary. Prognostication will occur no earlier than 72 hours post-cardiac arrest to prevent premature withdrawal of life-sustaining treatment. Transfer times estimated from the 40-patient pilot are anticipated to be 100 minutes (median; IQR 75 to 113) from time of arrest to the designated centre.
Procedure: Transfer to cardiac arrest centre
Patients in the intervention arm will be taken directly to a the catheter lab of a heart attack centre.

No Intervention: Control Arm: Current standard of care
The control arm comprises the current standard of pre-hospital advanced life support (ALS) care management for patients with ROSC following cardiac arrest of suspected cardiac aetiology. The patient is conveyed to the geographically closest emergency department. Management thereafter will be as per standard hospital protocols however as in the intervention arm, prognostication is to be delayed in trial patients until at least 72 hours post arrest.



Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 30 days after randomisation ]

Secondary Outcome Measures :
  1. Cerebral performance category score [ Time Frame: Discharge (capped at 30 days) ]
    Neurological status assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)

  2. Modified Rankin Score [ Time Frame: Discharge (capped at 30 days) ]
    Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).

  3. Cerebral performance category score [ Time Frame: 3 months after randomisation ]
    Neurological assessed using the cerebral performance category (ranked scale from 1 to 5 with 1 being the best outcome and 5 the worse outcome)

  4. Modified Rankin Score [ Time Frame: 3 months after randomisation ]
    Neurological status assessed using the modified Ranking Score (ranked scale from 0 to 6 with 0 being the better outcome and 6 the worse outcome).

  5. All-cause mortality [ Time Frame: 3 months after randomisation ]
  6. All-cause mortality [ Time Frame: 6 months after randomisation ]
  7. All-cause mortality [ Time Frame: 12 months after randomisation ]
  8. Patient's quality of life [ Time Frame: Discharge (capped at 30 days) ]
    Assessed using the EuroQol-5 Dimension-5 Level (EQ-5D-5L) standardised survey



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-of-hospital cardiac arrest (OHCA)
  • Return of spontaneous circulation (ROSC)
  • Age 18 or over (known or presumed)
  • Absence of non-cardiac cause (for example; trauma, drowning, suicide, drug overdose)

Exclusion Criteria:

  • Criteria for ST-elevation myocardial infarction on 12-Lead electrocardiogram (ECG)
  • Do Not Attempt Resuscitation (DNAR) Order
  • Cardiac arrest suffered after care pathway set and patient en route
  • Suspected pregnancy

Information from the National Library of Medicine

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): NCT03872960


Contacts
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Contact: Alexander D Perkins, MSc +44 020 7927 2723 alexander.perkins@lshtm.ac.uk
Contact: Tiffany Patterson, MBBS, PhD tiffanypatterson05@gmail.com

Locations
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United Kingdom
Dartford and Gravesham NHS Trust Active, not recruiting
Dartford, United Kingdom
Barts Health NHS Trust Active, not recruiting
London, United Kingdom
BHR University Hospitals NHS Trust Active, not recruiting
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust Active, not recruiting
London, United Kingdom
Croydon Health Services NHS Trust Active, not recruiting
London, United Kingdom
Epsom and St Helier University Hospitals NHS Trust Active, not recruiting
London, United Kingdom
Guy's and St Thomas' NHS FT Active, not recruiting
London, United Kingdom
Hillingdon Hospitals NHS Trust Active, not recruiting
London, United Kingdom
Homerton University Hospital NHS Trust Active, not recruiting
London, United Kingdom
Imperial College Healthcare NHS Trust Active, not recruiting
London, United Kingdom
King's College Hospital NHS Foundation Trust Active, not recruiting
London, United Kingdom
Kingston Hospital NHS FT Active, not recruiting
London, United Kingdom
Lewisham & Greenwich NHS Trust Active, not recruiting
London, United Kingdom
London Ambulance Service NHS Trust Recruiting
London, United Kingdom
Contact: Adam Smith         
Principal Investigator: Mark Whitbread         
London North West University Healthcare Active, not recruiting
London, United Kingdom
North Middlesex University Hospital NHS Trust Active, not recruiting
London, United Kingdom
Royal Brompton and Harefield NHS Trust Active, not recruiting
London, United Kingdom
Royal Free London NHS Foundation Trust Active, not recruiting
London, United Kingdom
St George's University Hospitals NHS Foundation Trust Active, not recruiting
London, United Kingdom
Surrey and Sussex Healthcare NHS Trust Active, not recruiting
London, United Kingdom
University College London Hospitals NHS Foundation Trust Active, not recruiting
London, United Kingdom
West Hertfordshire Hospitals NHS Trust Active, not recruiting
Watford, United Kingdom
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
London School of Hygiene and Tropical Medicine
Barts & The London NHS Trust
King's College Hospital NHS Trust
Imperial College Healthcare NHS Trust
Royal Brompton & Harefield NHS Foundation Trust
Royal Free Hospital NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
London Ambulance Service
Investigators
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Principal Investigator: Simon Redwood, MBBS, PhD Guy's and St Thomas' NHS Foundation Trust

Additional Information:
Publications:
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03872960     History of Changes
Other Study ID Numbers: MJKTUAR
ISRCTN96585404 ( Registry Identifier: ISRCTN )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
cardiac arrest
pre-hospital care
strategy trial
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases