Health TrialsbyHealthPanel

Early Neuroprognostication After OHCA

ConditionsCardiac ArrestNeurological OutcomeEEGCTBrain InjuriesBiomarkers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorLund University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

On ECMO prior to randomisation

Pregnancy

Suspected or confirmed intracranial hemorrhage

Previously randomised in the STEPCARE trial

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Functional outcome

Poor outcome defined as modified Rankin Scale 4-6

Time frame
Six months post-randomisation

Secondary outcomes

1

Blood levels of brain injury markers

Neurofilament light

Time frame
Samples collected at 12-72 hours post-randomisation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Helsingborgs Hospital

Collaborator

University of Helsinki

Collaborator

Skane University Hospital

Collaborator

Charite University, Berlin, Germany

Collaborator

Source ClinicalTrials.gov
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