Early assessment of brain recovery after cardiac arrest
Official title: Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
Run by Lund University · NCT05706194 · Data updated 2026-11-12
This study is testing if doctors can predict brain recovery sooner than usual for adults who have had a cardiac arrest by using a mix of exams and tests within 24 hours.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Lund University Academic / other |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | July 31, 2029 |
| Registry record updated | March 21, 2024 |
| Trial ID | NCT05706194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients who have experienced an out-of-hospital cardiac arrest of non-traumatic cause and are eligible for intensive care.
✕Probably not a fit
Patients on ECMO prior to randomization or those with suspected intracranial hemorrhage may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational substudy aims to determine if neurological prognostication after out-of-hospital cardiac arrest can be performed sooner than the current 72-hour guideline. It will evaluate the combination of clinical examination, neurofilament light (NFL) levels, electroencephalography (EEG), and head computed tomography (CT) to predict poor functional outcomes at 24 hours post-arrest. The study will involve adult patients who have experienced a cardiac arrest and will be recruited from over 80 hospitals participating in the larger STEPCARE trial. The goal is to enhance the accuracy of early prognostic assessments without false positives.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate predictions of neurological outcomes for patients after cardiac arrest.
How similar studies have gone: Other studies have explored similar prognostic approaches, but this specific combination of methods is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Helsinki Hospital
Helsinki, Finland Recruiting -
Charité University Hospital
Berlin, Germany Recruiting -
Helsingborgs Hospital
Helsingborg, Sweden Recruiting -
Skane University Hospital
Lund, Sweden Recruiting
Study contacts
- Study coordinator: Marion Moseby-Knappe, MD, PhD
- Email: marion.moseby_knappe@med.lu.se
- Phone: 00464671000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.