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

RECRUITINGSponsored by Region Skane
Actively Recruiting
SponsorRegion Skane
Started2023-10-01
Est. completion2027-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

Cardiac ArrestHeart Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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