Cardiac ArrestNCT06471972
Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
An observational study of Cardiac Arrest, run by Region Skane at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- How many people
- 1,500 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2023to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with an out-of-hospital cardiac arrest from sites participating in the biobank substudy of the STEPCARE trial will be included.
Who may be able to join
- 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
Who cannot join
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Sweden3 sites
Helsingborgs Hospital
Helsingborg
Skåne university hospital
Lund
Skåne University Hospital
Malmö
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Keywords
- Biomarkers, Brain injury
- Medical subject headings
- Heart Arrest, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomisation
Secondary outcomes (2)
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.
Measured: 30 days after randomisation
Mortality at 6 months
Mortality from any cause at six months follow-up
Measured: 6 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Oct 2023
- Primary completion30 May 2026
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, The George Institute, Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical Research Institute of New Zealand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471972
- Sponsor's protocol ID
- STEPCARE biomarker substudy
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2024
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon reasonable request following publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy
- ClinicalTrials.gov ID
- NCT06471972
- Acronym / sponsor ID
- STEPCARE biomarker substudy
- Conditions
- Cardiac Arrest
- Keywords
- Biomarkers, Brain injury
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- University of Helsinki, The George Institute, Copenhagen Trial Unit, Center for Clinical Intervention Research, Medical Research Institute of New Zealand
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an out-of-hospital cardiac arrest from sites participating in the biobank substudy of the STEPCARE trial will be included.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- On ECMO prior to randomization
- Pregnancy
- Suspected or confirmed intracranial hemorrhage
- Previously randomized in the STEPCARE trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Functional outcome according to the modified Rankin Scale
Time frame: 6 months after randomisation
Poor functional outcome modified Rankin Scale 4-6 (moderately severe disability, severe disability or death). A higher score indicates a worse score.
2 secondary outcomes
Functional outcome according to the modified Rankin Scale
Time frame: 30 days after randomisation
Mortality at 6 months
Time frame: 6 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Website for the trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon reasonable request following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by Region Skane at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome according to the modified Rankin Scale (time frame: 6 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.