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

NCT06471972 | Recruiting DMC

• 1 other identifier: STEPCARE biomarker substudy
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cardiac Arrest

Keywords

Biomarkers; Brain injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Functional outcome according to the modified Rankin Scale

  30 days after randomisation

• Mortality at 6 months

  6 months after randomisation

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• On ECMO prior to randomization
• Pregnancy
• Suspected or confirmed intracranial hemorrhage
• Previously randomized in the STEPCARE trial.

Sponsors & Collaborators

• Region Skane: lead
• University of Helsinki: collaborator
• The George Institute: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Medical Research Institute of New Zealand: collaborator

Study Sites (4)

Helsinki Hospital

Helsinki, Finland

RECRUITING

Helsingborgs Hospital

Helsingborg, Sweden

RECRUITING

Skåne university hospital

Lund, Sweden

RECRUITING

Skåne University Hospital

Malmo, Sweden

RECRUITING

Related Links

• Website for the trial

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma and PAX-RNA will be collected. Blood will be sampled at 12, 24, 48 and 72 h after inclusion in STEPCARE.

MeSH Terms

Conditions

Heart Arrest; Brain Injuries

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

SE (3); FI (1)