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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03913065
Registration number
NCT03913065
Ethics application status
Date submitted
5/04/2019
Date registered
12/04/2019
Date last updated
23/01/2023
Titles & IDs
Public title
Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest
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Scientific title
Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy
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Secondary ID [1]
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TTM-2 CT-substudy
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Arrest, Out-Of-Hospital
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Computed Tomography
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Unconsciousness
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Neurologic Deficits
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Condition category
Condition code
Neurological
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Other neurological disorders
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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational [Patient Registry]
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Diagnosis / Prognosis - CT
Included patients - Cardiac arrest patients from sites participating in the TTM-2 CT-substudy still unconscious 48 hours after cardiac arrest are routinely examined with head computed tomography as soon as possible after inclusion.
Diagnosis / Prognosis: CT
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).
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Poor functional outcome
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Assessment method [1]
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Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
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Timepoint [1]
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180 days
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Secondary outcome [1]
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Exploratory: Neurocognitive outcome
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Assessment method [1]
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Montreal Cognitive Assessment Scale (MoCA), ranges from 0-30, a score above 26 is considered normal.
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Timepoint [1]
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180 days
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Secondary outcome [2]
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Exploratory: Neurocognitive outcome
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Assessment method [2]
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Symbol Digit Modalities Test (SDMT)
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Timepoint [2]
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180 days
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Secondary outcome [3]
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Exploratory: Functional outcome
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Assessment method [3]
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Glasgow Outcome Scale-Extended version (GOS-E)
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Timepoint [3]
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180 days
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2023
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Sweden
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State/province [1]
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Skania
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Funding & Sponsors
Primary sponsor type
Other
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Name
Lund University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Region Skane
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Charite University, Berlin, Germany
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Halmstad County Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Other
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Name [4]
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Sahlgrenska University Hospital, Sweden
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Karlstad Central Hospital
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Address [5]
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Country [5]
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Other collaborator category [6]
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Other
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Name [6]
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Medical University Innsbruck
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Address [6]
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Country [6]
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Other collaborator category [7]
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Other
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Name [7]
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University Hospital of Wales
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Address [7]
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Country [7]
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Other collaborator category [8]
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Other
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Name [8]
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Hopital Lariboisière
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Address [8]
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Country [8]
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Other collaborator category [9]
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Other
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Name [9]
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Nantes University Hospital
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Address [9]
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Country [9]
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Other collaborator category [10]
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Other
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Name [10]
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University Hospital, Linkoeping
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Address [10]
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Country [10]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03913065
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Marion Moseby-Knappe, MD
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Address
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Lund University and Skane University Hospitals Sweden
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03913065
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