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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05706194




Registration number
NCT05706194
Ethics application status
Date submitted
9/01/2023
Date registered
31/01/2023
Date last updated
21/03/2024

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:
Advanced/Metastatic Solid Tumors 0 0
Cardiac Arrest 0 0
Neurological Outcome 0 0
EEG 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2029
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Lund University
Address
Country

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/study/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
[email protected]
Contact person for scientific queries



Summary Results

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