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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 hours after return of spontaneous circulation (ROSC)
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 72 hours after randomization
Participants are monitored with blood sample collections to study biomarkers after cardiac arrest.
4 blood sample collections at 12, 24, 48, and 72 hours (in-person)
Duration - 6 months after randomization
Participants' functional outcomes and survival are assessed after the initial monitoring period.
2 follow-up assessments at 30 days and 6 months (in-person or remote)
Trial Site Locations
Total: 4 locations
1
Helsinki Hospital
Helsinki, Finland
Actively Recruiting
2
Helsingborgs Hospital
Helsingborg, Sweden
Actively Recruiting
3
Skåne university hospital
Lund, Sweden
Actively Recruiting
4
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
Research Team
M
Marion Moseby-Knappe, MD, PhD
N
Niklas Nielsen, Prof, Principal Investigator
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here