Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913065
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Region Skane
Charite University, Berlin, Germany
Halmstad County Hospital
Sahlgrenska University Hospital, Sweden
Karlstad Central Hospital
Medical University Innsbruck
University Hospital of Wales
Hopital Lariboisière
Nantes University Hospital
University Hospital, Linkoeping
Information provided by (Responsible Party):
Lund University

Tracking Information
First Submitted Date April 5, 2019
First Posted Date April 12, 2019
Last Update Posted Date April 12, 2019
Actual Study Start Date November 18, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2019)
Poor functional outcome [ Time Frame: 180 days ]
Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 11, 2019)
  • Exploratory: Neurocognitive outcome [ Time Frame: 180 days ]
    Montreal Cognitive Assessment Scale (MoCA)
  • Exploratory: Neurocognitive outcome [ Time Frame: 180 days ]
    Symbol Digit Modalities Test (SDMT)
  • Exploratory: Functional outcome [ Time Frame: 180 days ]
    Glasgow Outcome Scale-Extended version (GOS-E)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest
Official Title Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
Serum samples collected in the main trial TTM-2 (ClinicalTrials.gov Identifier: NCT02908308)
Sampling Method Probability Sample
Study Population Adult patients with Out-of hospital cardiac arrest included in the TTM-2 trial and randomized to either targeted temperature management at 33°C or early treatment of fever.
Condition
  • Heart Arrest, Out-Of-Hospital
  • Computed Tomography
  • Unconsciousness
  • Neurologic Deficits
Intervention Diagnostic Test: 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).
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: CT
Publications * Moseby-Knappe M, Pellis T, Dragancea I, Friberg H, Nielsen N, Horn J, Kuiper M, Roncarati A, Siemund R, Undén J, Cronberg T; TTM-trial investigators. Head computed tomography for prognostication of poor outcome in comatose patients after cardiac arrest and targeted temperature management. Resuscitation. 2017 Oct;119:89-94. doi: 10.1016/j.resuscitation.2017.06.027. Epub 2017 Jul 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 11, 2019)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marion Moseby-Knappe, MD 0046 46171000 marion.moseby_knappe@med.lu.se
Contact: Tobias Cronberg, MD, PhD 0046 46171000 tobias.cronberg@skane.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT03913065
Other Study ID Numbers TTM-2 CT-substudy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Lund University
Study Sponsor Lund University
Collaborators
  • Region Skane
  • Charite University, Berlin, Germany
  • Halmstad County Hospital
  • Sahlgrenska University Hospital, Sweden
  • Karlstad Central Hospital
  • Medical University Innsbruck
  • University Hospital of Wales
  • Hopital Lariboisière
  • Nantes University Hospital
  • University Hospital, Linkoeping
Investigators
Principal Investigator: Marion Moseby-Knappe, MD Lund University and Skane University Hospitals Sweden
Principal Investigator: Tobias Cronberg, MD, PhD Lund University and Skane University Hospitals Sweden
PRS Account Lund University
Verification Date April 2019