Early assessment of brain recovery after cardiac arrest
Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT05706194 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients on ECMO prior to randomization or those with suspected intracranial hemorrhage may not benefit from this study.
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 performed: Other studies have explored similar prognostic approaches, but this specific combination of methods is novel.
Eligibility criteria
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 this trial is running
Helsinki and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.