Trial Review

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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
Scientific title
Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
Secondary ID [1] 0 0
STEPCARE EARLY-NEURO
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest 0 0
Neurological Outcome 0 0
EEG 0 0
CT 0 0
Brain Injuries 0 0
Biomarkers 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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)
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Functional outcome
Timepoint [1] 0 0
Six months post-randomisation
Secondary outcome [1] 0 0
Blood levels of brain injury markers
Timepoint [1] 0 0
Samples collected at 12-72 hours post-randomisation

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
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Finland
State/province [1] 0 0
Helsinki
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Sweden
State/province [3] 0 0
Helsingborg
Country [4] 0 0
Sweden
State/province [4] 0 0
Lund

Funding & Sponsors
Primary sponsor type
Other
Name
Lund University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Helsingborgs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Helsinki
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Skane University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Charite University, Berlin, Germany
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05706194
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Niklas Nielsen, MD, PhD
Address 0 0
Lund University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marion Moseby-Knappe, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
00464671000
Fax 0 0
Email 0 0
marion.moseby_knappe@med.lu.se
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05706194