An observational study in Cardiac Arrest, sponsored by Region Skane. Active, not recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Region Skane · Observational
A prospective multicenter biomarker study with adult patients treated on
intensive care units after out-of-hospital cardiac arrest. Patients will be recruited from specific sites participating in the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE) trial. (ClinicalTrials.gov ID NCT05564754).
Blood samples will be collected at 12, 24, 48, and 72 hours after randomization in selected sites, aliquoted and frozen on-site. After trial completion, samples will be stored in a central biobank. Sample analysis will be performed in batch after trial completion. Functional outcome will be assessed at 30 days and 6 months after cardiac arrest.
A prospective multicenter biomarker study with adult patients treated on intensive care units after out-of-hospital cardiac arrest. Patients will be recruited from specific sites participating in the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation (STEPCARE) trial. (ClinicalTrials.gov ID NCT05564754). The STEPCARE-trial is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac arrest and who are comatose. It will include three different interventions focusing on sedation targets, temperature targets and mean arterial pressure targets.
3500 patients who are comatose after cardiac arrest will be included in the STEPCARE trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets as follows:
Hospitals participating in the STEPCARE trial may opt to participate in the biomarker substudy if they include >20 patients/year, have the possibility to collect and process samples 24/7. Processing should be done by professional or experienced personnel.
Blood samples will be collected at 12, 24, 48, and 72 hours after randomization in selected sites, aliquoted and frozen on-site. Serum, plasma and PAX-RNA vials are collected. After trial completion, samples will be stored in a central biobank. Sample analysis will be performed in batch after trial completion.
Functional outcome will be assessed at 30 days and 6 months after cardiac arrest. Primary outcome is poor functional outcome (modified Rankin Scale 4-6) at six months. Secondary outcomes are poor functional outcome at 30 days and survival at 6 months.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 1,500 is above the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with an out-of-hospital cardiac arrest from sites participating in the biobank substudy of the STEPCARE trial will be included.
Inclusion Criteria:
Exclusion Criteria:
Patients will not be randomized within the biomarker substudy, but are already randomised as participants within the STEPCARE trial to either of 3 interventions
Functional outcome according to the modified Rankin Scale
Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score.
Time frame: 6 months after randomisation
Functional outcome according to the modified Rankin Scale
Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score.
Time frame: 30 days after randomisation
Mortality at 6 months
Mortality from any cause at six months follow-up
Time frame: 6 months after randomisation
Plan to share: Undecided — Upon reasonable request following publication.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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