NCT06471972 Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
| NCT ID | NCT06471972 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Skane |
| Condition | Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-10-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06471972 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06471972 currently recruiting?
Yes, NCT06471972 is actively recruiting participants. Contact the research team at marion.moseby_knappe@med.lu.se for enrollment information.
Where is the NCT06471972 trial being conducted?
This trial is being conducted at Helsinki, Finland, Helsingborg, Sweden, Lund, Sweden, Malmö, Sweden.
Who is sponsoring the NCT06471972 clinical trial?
NCT06471972 is sponsored by Region Skane. The trial plans to enroll 1,000 participants.