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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki Hospital
RECRUITING
Helsinki
Sweden
Helsingborgs Hospital
RECRUITING
Helsingborg
Skåne university hospital
RECRUITING
Lund
Skåne University Hospital
RECRUITING
Malmo
Contact Information
Primary
Marion Moseby-Knappe, MD, PhD
marion.moseby_knappe@med.lu.se
+464671000
Backup
Niklas Nielsen, Prof, Principal Investigator
niklas.nielsen@med.lu.se
+46424061000
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 1000
Treatments
Adult out-of-hospital cardiac arrest patients in participating sites of the STEPCARE trial
Patients will not be randomized within the biomarker substudy, but are already randomised as participants within the STEPCARE trial to either of 3 interventions
Related Therapeutic Areas
Sponsors
Collaborators: Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical Research Institute of New Zealand, University of Helsinki, The George Institute
Leads: Region Skane

This content was sourced from clinicaltrials.gov