Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
Sponsors
Source
Region Skane
Oversight Info
Has Dmc
Yes
Is Us Export
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Detailed Description
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). The STEPCARE-trial
is a 2x2x2 randomised trial studying patients who have been resuscitated from cardiac
arrest and who are comatose. It will include three different interventions focusing on
sedation targets, temperature targets and mean arterial pressure targets.
3500 patients who are comatose after cardiac arrest will be included in the STEPCARE
trial studying three separate targets. All patients will be randomised to a control or an
intervention arm for sedation, temperature and blood pressure targets as follows:
- Continuous deep sedation for 36 hours or minimal sedation (SEDCARE)
- Fever management with or without a feedback-controlled device (TEMPCARE)
- A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE)
Hospitals participating in the STEPCARE trial may opt to participate in the biomarker
substudy if they include >20 patients/year, have the possibility to collect and process
samples 24/7. Processing should be done by professional or experienced personnel.
Blood samples will be collected at 12, 24, 48, and 72 hours after randomization in
selected sites, aliquoted and frozen on-site. Serum, plasma and PAX-RNA vials are
collected. 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. Primary
outcome is poor functional outcome (modified Rankin Scale 4-6) at six months. Secondary
outcomes are poor functional outcome at 30 days and survival at 6 months.
Overall Status
Recruiting
Start Date
2023-10-01
Completion Date
2029-12-31
Primary Completion Date
2027-12-31
Study Type
Observational
Primary Outcome
Measure |
Time Frame |
|
Functional outcome according to the modified Rankin Scale |
6 months after randomisation |
Secondary Outcome
Measure |
Time Frame |
|
Functional outcome according to the modified Rankin Scale |
30 days after randomisation |
|
Mortality at 6 months |
6 months after randomisation |
Number Of Groups
1
Enrollment
1000
Condition
Eligibility
Study Pop
Adult patients with an out-of-hospital cardiac arrest from sites participating in the
biobank substudy of the STEPCARE trial will be included.
Sampling Method
Probability Sample
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Contact
Last Name
Marion Moseby-Knappe, MD, PhD
Phone
+464671000
marion.moseby_knappe@med.lu.se
Location
Facility |
Status |
Contact |
|
Helsinki Hospital Helsinki 658225 Finland |
Recruiting |
Last Name: Markus Skrifvars, Prof |
|
Helsingborgs Hospital Helsingborg 2706767 Sweden |
Recruiting |
Last Name: Niklas Nielsen, Prof |
|
Skåne university hospital Lund 2693678 Sweden |
Recruiting |
Last Name: Josef Dankiewicz, PhD |
|
Skåne University Hospital Malmo 2692969 Sweden |
Recruiting |
Last Name: Joachim Düring, PhD |
Location Countries
Country
Finland
Sweden
Verification Date
2024-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Adult out-of-hospital cardiac arrest patients in participating sites of the STEPCARE trial
Description
Patients will not be randomized within the biomarker substudy, but are already randomised
as participants within the STEPCARE trial to either of 3 interventions
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Niklas Nielsen, Prof, Principal Investigator
Phone
+46424061000
niklas.nielsen@med.lu.se
Biospec Retention
Samples Without DNA
Biospec Descr
Serum, plasma and PAX-RNA will be collected. Blood will be sampled at 12, 24, 48 and 72 h
after inclusion in STEPCARE.
Patient Data
Sharing Ipd
Undecided
Ipd Description
Upon reasonable request following publication.
Study Docs
Study Doc
Doc Type
Study Protocol
Doc Url
Doc Comment
Lab manuals and sample collection form
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Cohort
Time Perspective
Prospective
Study First Submitted
June 18, 2024
Study First Submitted Qc
June 18, 2024
Study First Posted
June 24, 2024
Last Update Submitted
September 4, 2024
Last Update Submitted Qc
September 4, 2024
Last Update Posted
September 19, 2024
ClinicalTrials.gov processed this data on November 26, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.