Cardiac Arrest Clinical Trial
Official title:
Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | July 31, 2029 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki Hospital | Helsinki | |
Germany | Charité University Hospital | Berlin | |
Sweden | Helsingborgs Hospital | Helsingborg | |
Sweden | Skane University Hospital | Lund |
Lead Sponsor | Collaborator |
---|---|
Lund University | Charite University, Berlin, Germany, Helsingborgs Hospital, Skane University Hospital, University of Helsinki |
Finland, Germany, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional outcome | Poor outcome defined as modified Rankin Scale 4-6 | Six months post-randomisation | |
Secondary | Blood levels of brain injury markers | Neurofilament light | Samples collected at 12-72 hours post-randomisation |
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