Ireland
--:--IST
Active, not recruiting Observational

Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy

NCT06471972 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2023-10-01
Last updated
2026-08-21

Condition(s) studied

Cardiac Arrest

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Functional outcome according to the modified Rankin Scale — 6 months after randomisation
    Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score.

Trial sites (4)

FacilityCityRegionStatus
Helsinki Hospital Helsinki Finland
Helsingborgs Hospital Helsingborg Sweden
Skåne university hospital Lund Sweden
Skåne University Hospital Malmö Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06471972 on ClinicalTrials.gov ↗ ← All trials in Sweden