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Clinical Trials in Germany / NCT05706194
Recruiting Observational

Early Neuroprognostication After OHCA

NCT05706194 · tracked via the Priya Life Science Germany tracker
Sponsor
Lund University
Phase
Observational
Started
2023-10-01
Last updated
2024-03-21

Condition(s) studied

Cardiac ArrestNeurological OutcomeEEGCTBrain InjuriesBiomarkers

Investigational drug(s) / intervention(s)

Early neurological prognostication with biomarkers, EEG and CT

Early neurological prognostication with biomarkers, EEG and CT: 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)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Adult cardiac arrest patients with an out-of-hospital cardiac arrest of non-traumatic cause treated at hospitals recruiting patients to the STEPCARE neuroprognostication substudy. Other inclusion criteria include: * 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 * Inclusion within 4 hours of ROSC Exclusion Criteria: * 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

Primary outcome measure(s)

  • Functional outcome — Six months post-randomisation
    Poor outcome defined as modified Rankin Scale 4-6

Trial sites (4)

FacilityCityRegionStatus
Helsinki Hospital Helsinki Finland Recruiting
Charité University Hospital Berlin Germany Recruiting
Helsingborgs Hospital Helsingborg Sweden Recruiting
Skane University Hospital Lund Sweden Recruiting

Other trials for the same condition

Resuscitation Registry in CHD Recruiting
Cerebral Small Vessel Disease Progression Dependent on Stroke Type Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05706194 on ClinicalTrials.gov ↗ ← All trials in Germany