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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05706194
Registration number
NCT05706194
Ethics application status
Date submitted
9/01/2023
Date registered
31/01/2023
Date last updated
31/01/2023
Titles & IDs
Public title
Early Neuroprognostication After OHCA
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Scientific title
Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
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Secondary ID [1]
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STEPCARE EARLY-NEURO
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest
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Neurological Outcome
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EEG
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CT
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Brain Injuries
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Biomarkers
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Condition category
Condition code
Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - Early neurological prognostication with biomarkers, EEG and CT
Diagnosis / Prognosis: Early neurological prognostication with biomarkers, EEG and CT
Biomarker samples collected at 12, 24, 48 and 72 h after randomisation, CT and EEG performed as early as possible after 24 h post randomisation in patients still unconscious (defined as not awake and able to follow verbal commands)
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Functional outcome
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Assessment method [1]
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Poor outcome defined as modified Rankin Scale 4-6
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Timepoint [1]
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Six months post-randomisation
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Secondary outcome [1]
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Blood levels of brain injury markers
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Assessment method [1]
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Neurofilament light
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Timepoint [1]
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Samples collected at 12-72 hours post-randomisation
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Eligibility
Key inclusion criteria
Adult cardiac arrest patients with an out-of-hospital cardiac arrest of non-traumatic cause
treated at hospitals recruiting patients to the STEPCARE neuroprognostication substudy.
Other inclusion criteria include:
- a minimum of 20 minutes without chest compressions
- Unconsciousness defined as not being able to obey verbal commands (FOUR-score motor
response of <4) or being intubated and sedated because of agitation after sustained
ROSC
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- On ECMO prior to randomisation
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomised in the STEPCARE trial
- Patients with limitations in level-of-care due to for example generalized malignancy
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/04/2023
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2027
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Finland
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State/province [1]
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Helsinki
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Country [2]
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Germany
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State/province [2]
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Berlin
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Country [3]
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Sweden
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State/province [3]
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Helsingborg
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Country [4]
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Sweden
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State/province [4]
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Lund
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lund University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Helsingborgs Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Helsinki
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Skane University Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Charite University, Berlin, Germany
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Address [4]
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Country [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective observational substudy of the STEPCARE trial ClinicalTrials.gov
Identifier: NCT05564754) with the aim to examine whether prognostication of neurological
outcome after cardiac arrest can be performed earlier than the 72 h time-point recommended by
guidelines today.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05706194
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Niklas Nielsen, MD, PhD
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Address
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Lund University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Marion Moseby-Knappe, MD, PhD
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Address
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Country
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Phone
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00464671000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05706194
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