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
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.
|Condition or disease||Intervention/treatment|
|Heart Arrest, Out-Of-Hospital Computed Tomography Unconsciousness Neurologic Deficits||Diagnostic Test: CT|
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]|
|Estimated Enrollment :||600 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy|
|Actual Study Start Date :||November 18, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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.
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).
- Poor functional outcome [ Time Frame: 180 days ]Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
- 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)
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913065
|Contact: Marion Moseby-Knappe, MD||0046 firstname.lastname@example.org|
|Contact: Tobias Cronberg, MD, PhD||0046 email@example.com|
|Lund, Skania, Sweden, 22185|
|Contact: Marion Moseby-Knappe, MD|
|Principal Investigator: Niklas Nielsen, MD, PhD|
|Principal Investigator: Hans Friberg, MD, PhD|
|Principal Investigator: Johan Undén, MD, PhD|
|Principal Investigator: Josef Dankiewicz, MD, PhD|
|Principal Investigator: Christoph Leithner, MD, PhD|
|Principal Investigator: Christian Storm, MD, PhD|
|Principal Investigator: Christian Rylander, MD, PhD|
|Sub-Investigator: Kasim Abul-Kasim, MD, PhD|
|Principal Investigator: Matt P Wise, MD, DPhil|
|Principal Investigator: Ola Borgquist, MD, PhD|
|Principal Investigator: Victoria Sem, MD, PhD|
|Principal Investigator: Nicolas Deye, MD, PhD|
|Principal Investigator: Raimund Helbok, MD, PhD|
|Principal Investigator: Thomas Halliday, MD, PhD|
|Principal Investigator: Alain Cariou, MD, PhD|
|Principal Investigator: Jean-Baptiste Lascarrou, MD, PhD|
|Principal Investigator: Joachim Düring, MD, PhD|
|Principal Investigator: Gisela Lilja, MD, PhD|
|Principal Investigator: Tobias Cronberg, MD, PhD|
|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|