Biomarkers After Out-of-hospital Cardiac Arrest- a STEPCARE Substudy

August 19, 2026 updated by: Region Skane

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Finland
- - Helsinki, Finland
    - Helsinki Hospital
Sweden
- - Helsingborg, Sweden
    - Helsingborgs hospital
  - Lund, Sweden
    - Skane University Hospital
  - Malmö, Sweden
    - Skane University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome according to the modified Rankin Scale Time Frame: 30 days after randomisation	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 Time Frame: 6 months after randomisation	Mortality from any cause at six months follow-up	6 months after randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

University of Helsinki

The George Institute

Copenhagen Trial Unit, Center for Clinical Intervention Research

Medical Research Institute of New Zealand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Website for the trial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

May 30, 2026

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

June 18, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

STEPCARE biomarker substudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request following publication.

Study Data/Documents

Study Protocol
Information comments: Lab manuals and sample collection form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.