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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| The George Institute | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Medical Research Institute of New Zealand |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome according to the modified Rankin Scale | Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score. | 6 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome according to the modified Rankin Scale | Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score. | 30 days after randomisation |
| Mortality at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with an out-of-hospital cardiac arrest from sites participating in the biobank substudy of the STEPCARE trial will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Moseby-Knappe, MD, PhD | Contact | +464671000 | marion.moseby_knappe@med.lu.se | |
| Niklas Nielsen, Prof, Principal Investigator | Contact | +46424061000 | niklas.nielsen@med.lu.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki Hospital | Recruiting | Helsinki | Finland |
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| Label | URL |
|---|---|
| Website for the trial | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Upon reasonable request following publication.
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| OTHER |
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Serum, plasma and PAX-RNA will be collected. Blood will be sampled at 12, 24, 48 and 72 h after inclusion in STEPCARE.
Mortality from any cause at six months follow-up |
| 6 months after randomisation |
| Helsingborgs Hospital | Recruiting | Helsingborg | Sweden |
|
| Skåne university hospital | Recruiting | Lund | Sweden |
|
| Skåne University Hospital | Recruiting | Malmö | Sweden |
|
Lab manuals and sample collection form |
| D009422 |
| Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |