Early Neuroprognostication After OHCA

NCT05706194 | Recruiting

• 1 other identifier: STEPCARE EARLY-NEURO
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 4

Brief Summary

This is a prospective observational substudy of the STEPCARE trial ClinicalTrials.gov Identifier: NCT05564754) with the aim to examine whether prognostication of neurological outcome after cardiac arrest can be performed earlier than the 72 h time-point recommended by guidelines today.

Conditions

Cardiac Arrest; Neurological Outcome; EEG; CT; Brain Injuries; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Functional outcome

  Poor outcome defined as modified Rankin Scale 4-6

  Six months post-randomisation

Secondary Outcomes (1)

• Blood levels of brain injury markers

  Samples collected at 12-72 hours post-randomisation

Interventions

Early neurological prognostication with biomarkers, EEG and CT DIAGNOSTIC_TEST

Biomarker samples collected at 12, 24, 48 and 72 h after randomisation, CT and EEG performed as early as possible after 24 h post randomisation in patients still unconscious (defined as not awake and able to follow verbal commands)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cardiac arrest patients with an out-of-hospital cardiac arrest of any non-traumatic cause treated at hospitals recruiting patients to the STEPCARE neuroprognostication substudy

You may qualify if:

• a minimum of 20 minutes without 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 randomisation
• Pregnancy
• Suspected or confirmed intracranial hemorrhage
• Previously randomised in the STEPCARE trial
• Patients with limitations in level-of-care due to for example generalized malignancy

Sponsors & Collaborators

• Lund University: lead
• Helsingborgs Hospital: collaborator
• University of Helsinki: collaborator
• Skane University Hospital: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (4)

Helsinki Hospital

Helsinki, Finland

RECRUITING

Charité University Hospital

Berlin, Germany

RECRUITING

Helsingborgs Hospital

Helsingborg, Sweden

RECRUITING

Skane University Hospital

Lund, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

MeSH Terms

Conditions

Heart Arrest; Brain Injuries

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Niklas Nielsen, MD, PhD

  Lund University

  STUDY CHAIR

Central Study Contacts

Marion Moseby-Knappe, MD, PhD

CONTACT

00464671000; marion.moseby_knappe@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: January 9, 2023
• First Posted: January 31, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

SE (2); FI (1); DE (1)