Cardiac Arrest, Out-Of-HospitalNCT06587763
Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Region Skane at 3 sites in Sweden.
Trial summary
Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital
- How many people
- 0 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Oct 2025to 31 Dec 2032
- Phase
- Observational
- Are there results?
- None posted in the registry
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 who survived to six months follow-up
Who may be able to join
- Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only
Who cannot join
- Patients not participating in the extended follow-up at participating sites
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Helsingborgs Hospital
Helsingborg
Skåne university hospital
Lund
Skåne University Hospital
Malmö
About this study
Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.
Read the detailed description
Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.
Samples will be analysed in batch for biomarkers of brain injury, inflammation etc.
Primary outcome is functional outcome (modified Rankin Scale 4-6) at six months after cardiac arrest.
Secondary outcomes are neurocognitive function according to the Montreal Cognitive Assessment (MoCA), Symbol Digits Modalities Test (SDMT).
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- Biomarkers, Brain injury, Inflammation, Dementia
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Brain Injuries, Inflammation, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Modified Rankin Scale 4-6
Measured: 6 months
Secondary outcomes (2)
Neurocognitive outcomes
Montreal Cognitive Assessment
Measured: 6 months
Neurocognitive outcomes
Symbol Digit Modalities Test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2032 (estimated)
Why it stopped: For logistical reasons, no patients were included before the main trial completed inclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest, Out-Of-HospitalStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, University of Helsinki
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587763
- Sponsor's protocol ID
- STEPCARE late biomarker study
- 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 after publication of results.
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
- Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06587763
- Acronym / sponsor ID
- STEPCARE late biomarker study
- Conditions
- Cardiac Arrest, Out-Of-Hospital
- Keywords
- Biomarkers, Brain injury, Inflammation, Dementia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: For logistical reasons, no patients were included before the main trial completed inclusion.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, University of Helsinki
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 19 Sep 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.
Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.
Detailed description
Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.
Samples will be analysed in batch for biomarkers of brain injury, inflammation etc.
Primary outcome is functional outcome (modified Rankin Scale 4-6) at six months after cardiac arrest.
Secondary outcomes are neurocognitive function according to the Montreal Cognitive Assessment (MoCA), Symbol Digits Modalities Test (SDMT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 who survived to six months follow-up
Key inclusion criteria (1 listed)
- Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only
Key exclusion criteria (1 listed)
- Patients not participating in the extended follow-up at participating sites
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
Time frame: 6 months
Modified Rankin Scale 4-6
2 secondary outcomes
Neurocognitive outcomes
Time frame: 6 months
Neurocognitive outcomes
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- trial HomepageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon reasonable request after publication of results.
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Cardiac Arrest, Out-Of-Hospital
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, Out-Of-Hospital, run by Region Skane at 3 sites in Sweden.
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 1 inclusion and 1 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: withdrawn, 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 3 sites in Sweden. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (time frame: 6 months). 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.