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Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest

Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03913065
Enrollment
400
Registered
2019-04-12
Start date
2017-11-18
Completion date
2023-03-12
Last updated
2024-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed Tomography, Heart Arrest, Out-Of-Hospital, Neurologic Deficits, Unconsciousness

Keywords

Cardiac arrest, Hypothermia, Neurological function, Cardiovascular disease, Cerebral oedema, Cerebral edema, Cerebral ischaemia, Cerebral ischemia, Gray-white-matter differentiation, Grey-white-matter differentiation, ROI, Regions of interest, CT, GWR, Neurological prognostication

Brief summary

The European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) joint guidelines for post-resuscitation care recommend a multimodal approach to prognostication of neurological outcome. However, head computed tomography (CT) which is commonly used for predicting long-term neurological outcome after cardiac arrest has not yet been examined prospectively in a clinical trial. The primary purpose of the TTM-2 CT-substudy is to prospectively investigate and compare various methods of diagnosing generalized oedema on CT after cardiac arrest and it´s ability to predict long-term neurological outcome.

Detailed description

This study is a sub-study to the international multicenter Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM-2) Trial (ClinicalTrials.gov Identifier: NCT02908308). All patients from participating centers still unconscious 48 hours after cardiac arrest will be routinely examined with CT. All other inclusion and exclusion criteria as well as treatment, neurological prognostication, withdrawal of life-sustaining therapy or follow-up will be handled according to TTM-2- protocol. Ethical approval for the main trial and this sub-study have been obtained from the Swedish Ethical Review Authority at Lund University (2015/228 and 2017/36). Both a patients´ next of kind or conscious patients have the opportunity to withdraw patients from the trial. Pseudonymized original CT images will be uploaded to a two-way secured digital platform from Lund University (LUSEC). Two study radiologists blinded from clinical data will perform analyses according to protocol. Various methods of diagnosing generalized oedema will be investigated including eye-balling (oedema yes/no), as well as manual and automated measurements of the differentiation between the grey and white matter (GWR) by placing circular regions of interest (ROI). Primary outcome is the neurological outcome at 6 months after cardiac arrest using the modified Rankin Scale (mRS). Secondary outcomes include neurocognitive outcomes such as the Glasgow Outcome Score-Extended version (GOS-E), Symbol-Digit-Modalities-Test (SDMT) and the Montreal Cognitive Assessment Score (MoCA). The results of the radiological evaluations will also be correlated with other markers of neuronal injury such as biomarkers, clinical neurological information or neurophysiological examinations. Additional analyses include evaluation of all available CT images of participating patients to investigate if there is any progression or regression of cerebral oedema.

Interventions

DIAGNOSTIC_TESTCT

Head computed tomography on patients still unconscious 48 hours after cardiac arrest.Visual evaluation of generalized oedema (eye-balling). Manual and automated measurement of the differentiation of gray and white matter (GWR) using circular regions of interest (ROI).

Sponsors

Region Skane
CollaboratorOTHER
Charite University, Berlin, Germany
CollaboratorOTHER
Halmstad County Hospital
CollaboratorOTHER
Sahlgrenska University Hospital
CollaboratorOTHER
Karlstad Central Hospital
CollaboratorOTHER
Medical University Innsbruck
CollaboratorOTHER
University Hospital of Wales
CollaboratorOTHER
Hopital Lariboisière
CollaboratorOTHER
Nantes University Hospital
CollaboratorOTHER
University Hospital, Linkoeping
CollaboratorOTHER
Lund University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Out-of-hospital cardiac arrest * Presumed cardiac cause of cardiac arrest * Unconscious with a FOUR-score \<M4 (not obeying verbal commands) * Stable return of spontaneous circulation (20 min) * Eligible for intensive care treatment without restrictions * Inclusion within 180 minutes of ROSC * Patient from participating centers, where head CT is routinely performed on all patients still unconscious 48 hours after cardiac arrest

Exclusion criteria

* Unwitnessed cardiac arrest with an initial rhythm of asystole * Temperature on admission \<30°C. * Obvious or suspected pregnancy * Intracranial bleeding * On ECMO prior to ROSC * Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy * Patients from centers not participating in the TTM-2 CT-substudy * Patients from participating centers not examined with head CT

Design outcomes

Primary

MeasureTime frameDescription
Poor functional outcome180 daysAssessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.

Secondary

MeasureTime frameDescription
Exploratory: Neurocognitive outcome180 daysMontreal Cognitive Assessment Scale (MoCA), ranges from 0-30, a score above 26 is considered normal.
Exploratory: Functional outcome180 daysGlasgow Outcome Scale-Extended version (GOS-E)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026