Biomarker analysis after cardiac arrest
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
This study is testing blood samples from adults who have had a cardiac arrest to see if certain markers can help understand brain injury and recovery after they are treated in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 4 sites (Helsinki and 3 other locations) |
| Trial ID | NCT06471972 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients who have experienced out-of-hospital cardiac arrest and are treated in intensive care units. It aims to collect blood samples at various time points after resuscitation to analyze biomarkers associated with brain injury. Patients will be recruited from sites participating in the STEPCARE trial, which investigates different interventions for sedation, temperature, and blood pressure management in comatose patients. The study will assess functional outcomes at 30 days and 6 months post-arrest.
Who should consider this trial
Good fit: Ideal candidates are adults who have suffered an out-of-hospital cardiac arrest and are comatose after resuscitation.
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 improved understanding and management of brain injury following cardiac arrest.
How similar studies have performed: Other studies have shown promise in analyzing biomarkers for brain injury after cardiac arrest, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * From sites participating in the STEPCARE biomarker substudy and withOut-of-hospital cardiac arrest * Sustained ROSC - defined as 20 minutes with signs of circulation without the need for 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 randomization * Pregnancy * Suspected or confirmed intracranial hemorrhage * Previously randomized in the STEPCARE trial.
Where this trial is running
Helsinki and 3 other locations
- Helsinki Hospital — Helsinki, Finland (Recruiting)
- Helsingborgs Hospital — Helsingborg, Sweden (Recruiting)
- Skåne university hospital — Lund, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
Study contacts
- Study coordinator: Marion Moseby-Knappe, MD, PhD
- Email: marion.moseby_knappe@med.lu.se
- Phone: +464671000
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.