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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
Scientific title
Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy
Secondary ID [1] 0 0
TTM-2 CT-substudy
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Arrest, Out-Of-Hospital 0 0
Computed Tomography 0 0
Unconsciousness 0 0
Neurologic Deficits 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Poor functional outcome
Timepoint [1] 0 0
180 days
Secondary outcome [1] 0 0
Exploratory: Neurocognitive outcome
Timepoint [1] 0 0
180 days
Secondary outcome [2] 0 0
Exploratory: Neurocognitive outcome
Timepoint [2] 0 0
180 days
Secondary outcome [3] 0 0
Exploratory: Functional outcome
Timepoint [3] 0 0
180 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Skania

Funding & Sponsors
Primary sponsor type
Other
Name
Lund University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Region Skane
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Charite University, Berlin, Germany
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Halmstad County Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Sahlgrenska University Hospital, Sweden
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Karlstad Central Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Medical University Innsbruck
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University Hospital of Wales
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Hopital Lariboisière
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Nantes University Hospital
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
University Hospital, Linkoeping
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03913065
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Marion Moseby-Knappe, MD
Address 0 0
Lund University and Skane University Hospitals Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries