Actively Recruiting
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Led by Region Skane · Updated on 2024-09-19
1000
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Region Skane
Lead Sponsor
U
University of Helsinki
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating biomarkers in adult patients who have been treated in intensive care units after experiencing out-of-hospital cardiac arrest. This study is part of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation STEPCARE trial, which is a randomized trial exploring different sedation, temperature, and blood pressure targets in comatose patients after cardiac arrest. The substudy focuses on collecting and analyzing blood samples to understand outcomes better. Blood samples are collected at 12, 24, 48, and 72 hours after randomization at selected sites that participate in the biomarker substudy. These samples, including serum, plasma, and PAX-RNA vials, are processed and frozen on-site before being sent to a central biobank for batch analysis after the trial ends. Patients in this substudy have already been randomized in the main STEPCARE trial to different sedation, temperature, and blood pressure intervention groups. Participants will have their functional outcome assessed at 30 days and 6 months after cardiac arrest, with the primary outcome being poor functional outcome measured by the modified Rankin Scale at six months. Survival at 6 months and functional outcomes at 30 days are also measured. The study involves intensive care treatment and monitoring, with data collected during the hospital stay and follow-up assessments to evaluate recovery and survival over time.
CONDITIONS
Brief Title
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is from a site participating in the STEPCARE biomarker substudy with out-of-hospital cardiac arrest
- Sustained return of spontaneous circulation (ROSC) for at least 20 minutes without chest compressions
- Unconsciousness defined as inability to obey verbal commands or intubated and sedated due to agitation after ROSC
- Eligible for intensive care without restrictions or limitations
- Inclusion within 4 hours of ROSC
You will not qualify if you...
- On extracorporeal membrane oxygenation (ECMO) before randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial
Research Team
M
Marion Moseby-Knappe, MD, PhD
N
Niklas Nielsen, Prof, Principal Investigator
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