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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/NCT01946932
Registration number
NCT01946932
Ethics application status
Date submitted
12/09/2013
Date registered
20/09/2013
Date last updated
5/12/2013
Titles & IDs
Public title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
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Scientific title
Cognitive Impairment Following Cardiac Arrest and Target Temperature Management
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Secondary ID [1]
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TTMcogsub
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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
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Out-of-hospital Cardiac Arrest
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Cognition Disorders
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Brain Injury
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Condition category
Condition code
Injuries and Accidents
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Other injuries and accidents
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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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Mental Health
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Other mental health disorders
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Mental Health
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Learning disabilities
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Neurological
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Dementias
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Temperature treatment
Active Comparator: Cardiac Arrest 33° - survivors with temperature treatment 33°
Active Comparator: Cardiac Arrest survivors 36° - survivors with temperature treatment 36°
Other interventions: Temperature treatment
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Intervention code [1]
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Other interventions
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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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Rivermead Behavioural Memory Test (RBMT)
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Assessment method [1]
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Memory test
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Timepoint [1]
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180 days after Cardiac Arrest (CA) or Myocardial Infarction (MI)
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Primary outcome [2]
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Frontal Assessment Battery (FAB)
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Assessment method [2]
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Screening of Executive functions
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Timepoint [2]
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180 days after CA or MI
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Primary outcome [3]
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Symbol Digit Modalities Test (SDMT)
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Assessment method [3]
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Assess attention, mental speed and concentration
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Timepoint [3]
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180 days after CA or MI
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Secondary outcome [1]
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Mayo-Portland Adaptability Inventory-4 (MPAI-4)
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Assessment method [1]
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Self rating of impairments, adjustment, and participation (in the society)
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Timepoint [1]
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180 days after CA or MI
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Secondary outcome [2]
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Short-Form Questionnaire 36 version 2 (SF-36v2)
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Assessment method [2]
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Questionnaire of health-related quality of life, both for patient and informant/relative/caregiver
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Timepoint [2]
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180 days after CA or MI
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Secondary outcome [3]
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Zarit Burden Interview
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Assessment method [3]
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Questionnaire for caregiver/informant/relative's perception of burden
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Timepoint [3]
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180 days after CA or MI
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Secondary outcome [4]
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Hospital Anxiety and Depression rating Scale (HADS)
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Assessment method [4]
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Anxiety and Depression questionnaire
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Timepoint [4]
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180 days after CA or MI
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Secondary outcome [5]
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Two Simple Questions (TSQ)
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Assessment method [5]
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Self rating of everyday activities and cognition
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Timepoint [5]
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180 days after CA or MI
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Secondary outcome [6]
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Informant Questionnaire on Cognitive Decline (IQCODE)
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Assessment method [6]
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Patients cognitive functioning in everyday life, questionnaire completed by informant/relative/caregiver
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Timepoint [6]
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180 days after CA or MI
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Secondary outcome [7]
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MiniMental Status Examination (MMSE)
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Assessment method [7]
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General cognitive screening
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Timepoint [7]
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180 days after CA or MI
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Secondary outcome [8]
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Cerebral Performance Category (CPC)
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Assessment method [8]
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Scale for general neurological outcome
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Timepoint [8]
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180 days after CA or MI
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Secondary outcome [9]
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modified Rankin Scale
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Assessment method [9]
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Scale for general outcome
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Timepoint [9]
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180 days after CA or MI
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Eligibility
Key inclusion criteria
- Age 18 years or older
- Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
- Unconsciousness after sustained return of spontaneous circulation (ROSC)
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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
Exclusion Criteria at time for inclusion in the TTM study:
- Known bleeding diathesis
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed stroke
- Unwitnessed asystole
- Known limitations in therapy and Do Not Resuscitate-order
- Known disease making 180 days survival unlikely
- Known prearrest status Cerebral Performance Category (CPC)3 or 4
- Temperature <30°on admission
- 4 hours (240 minutes) from ROSC to screening
- Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or
inotropic medication/intra aortic balloon pump
- In-hospital cardiac arrest
- OHCA of presumed non-cardiac arrest cause
Additional Exclusion criteria for the sub-study:
- Disability to speak the site language well enough to complete tests without
interpreter
- Controls should never have suffered a cardiac arrest
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
1/06/2011
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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
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Actual
1/11/2013
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Sample size
Target
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Accrual to date
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Final
287
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Denmark
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Copenhagen
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Italy
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Genova
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Italy
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Pordenone
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Italy
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State/province [4]
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Trieste
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Netherlands
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Amsterdam
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Netherlands
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Arnhem
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Netherlands
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Leeuwarden
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Sweden
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Gothenburg
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Sweden
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Helsingborg
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Sweden
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State/province [10]
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Karlstad
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Sweden
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Lund
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Sweden
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Malmoe
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Sweden
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State/province [13]
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Örebro
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United Kingdom
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State/province [14]
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Bournemouth
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United Kingdom
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Cardiff
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United Kingdom
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London
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United Kingdom
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State/province [17]
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Reading
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Funding & Sponsors
Primary sponsor type
Other
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Name
Region Skane
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Lund University
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Copenhagen University Hospital, Denmark
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Azienda Ospedaliera Santa Maria Degli Angeli
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Copenhagen Trial Unit, Center for Clinical Intervention Research
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Address [5]
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Other collaborator category [6]
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Other
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University Hospital of Wales
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Address [6]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a steering group approved substudy to the Target Temperature Management trial (TTM,
ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly
controlled temperature regimes for survivors of out-of-hospital cardiac arrest.
The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac
arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control
patients with myocardial infarction.
Our secondary aims are:
- To investigate the impact of cognitive impairment on our patients' ability to
participate in society and their health related quality of life.
- To investigate the relationship between our patients cognitive impairments and their
relatives/informants health related quality of life and feelings of burden.
- To test the hypothesis that the simple cognitive screening battery used in the TTM main
trial is sensitive enough to detect all patients with significant cognitive disability.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01946932
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Trial related presentations / publications
Cronberg T, Lilja G, Rundgren M, Friberg H, Widner H. Long-term neurological outcome after cardiac arrest and therapeutic hypothermia. Resuscitation. 2009 Oct;80(10):1119-23. doi: 10.1016/j.resuscitation.2009.06.021. Epub 2009 Jul 23.
Nielsen N, Wetterslev J, al-Subaie N, Andersson B, Bro-Jeppesen J, Bishop G, Brunetti I, Cranshaw J, Cronberg T, Edqvist K, Erlinge D, Gasche Y, Glover G, Hassager C, Horn J, Hovdenes J, Johnsson J, Kjaergaard J, Kuiper M, Langorgen J, Macken L, Martinell L, Martner P, Pellis T, Pelosi P, Petersen P, Persson S, Rundgren M, Saxena M, Svensson R, Stammet P, Thoren A, Unden J, Walden A, Wallskog J, Wanscher M, Wise MP, Wyon N, Aneman A, Friberg H. Target Temperature Management after out-of-hospital cardiac arrest--a randomized, parallel-group, assessor-blinded clinical trial--rationale and design. Am Heart J. 2012 Apr;163(4):541-8. doi: 10.1016/j.ahj.2012.01.013.
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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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Tobias Cronberg, MD, PhD
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Address
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Department of Clinical Sciences, Lund University, Lund, Sweden and Department of Neurology, Skåne University Hospital, Lund, Sweden
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01946932
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