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| Name | Class |
|---|---|
| Region Skane | OTHER |
| Charite University, Berlin, Germany | OTHER |
| Halmstad County Hospital | OTHER |
| Sahlgrenska University Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Poor functional outcome | Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome. | 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Neurocognitive outcome | Montreal Cognitive Assessment Scale (MoCA), ranges from 0-30, a score above 26 is considered normal. | 180 days |
| Exploratory: Neurocognitive outcome | Symbol Digit Modalities Test (SDMT) |
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Inclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Marion Moseby-Knappe, MD | Lund University and Skane University Hospitals Sweden | Principal Investigator |
| Tobias Cronberg, MD, PhD | Lund University and Skane University Hospitals Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marion Moseby-Knappe | Lund | Skåne County | 22185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28687281 | Result | Moseby-Knappe M, Pellis T, Dragancea I, Friberg H, Nielsen N, Horn J, Kuiper M, Roncarati A, Siemund R, Unden 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. | |
| 40499676 |
| Label | URL |
|---|---|
| Website of the TTM2 trial | View source |
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| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| D014474 | Unconsciousness |
| D009461 | Neurologic Manifestations |
| D006323 | Heart Arrest |
| D007035 | Hypothermia |
| D002318 | Cardiovascular Diseases |
| D001929 | Brain Edema |
| D002544 | Cerebral Infarction |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| OTHER |
| Karlstad Central Hospital | OTHER |
| Medical University Innsbruck | OTHER |
| University Hospital of Wales | OTHER |
| Hopital Lariboisière | OTHER |
| Nantes University Hospital | OTHER |
| University Hospital, Linkoeping | OTHER |
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Serum samples collected in the main trial TTM-2 (ClinicalTrials.gov Identifier: NCT02908308)
|
| 180 days |
| Exploratory: Functional outcome | Glasgow Outcome Scale-Extended version (GOS-E) | 180 days |
| Derived |
| Lang M, Kenda M, Scheel M, Martola J, Wheeler M, Owen S, Johnsson M, Annborn M, Dankiewicz J, Deye N, During J, Halliday T, Jakobsen JC, Lascarrou JB, Levin H, Lilja G, Lybeck A, McGuigan PJ, Rylander C, Sem V, Thomas M, Ullen S, Unden J, Wise MP, Cronberg T, Wasselius J, Nielsen N, Leithner C, Moseby-Knappe M. Radiological signs of hypoxic-ischaemic encephalopathy on head computed tomography for prediction of poor functional outcome after cardiac arrest - a prospective observational cohort study. Resuscitation. 2025 Sep;214:110675. doi: 10.1016/j.resuscitation.2025.110675. Epub 2025 Jun 9. |
| 38900283 | Derived | Lang M, Kenda M, Scheel M, Martola J, Wheeler M, Owen S, Johnsson M, Annborn M, Dankiewicz J, Deye N, During J, Friberg H, Halliday T, Jakobsen JC, Lascarrou JB, Levin H, Lilja G, Lybeck A, McGuigan P, Rylander C, Sem V, Thomas M, Ullen S, Unden J, Wise MP, Cronberg T, Wasselius J, Nielsen N, Leithner C, Moseby-Knappe M. Standardised and automated assessment of head computed tomography reliably predicts poor functional outcome after cardiac arrest: a prospective multicentre study. Intensive Care Med. 2024 Jul;50(7):1096-1107. doi: 10.1007/s00134-024-07497-2. Epub 2024 Jun 20. |
| 36267356 | Derived | Lang M, Leithner C, Scheel M, Kenda M, Cronberg T, During J, Rylander C, Annborn M, Dankiewicz J, Deye N, Halliday T, Lascarrou JB, Matthew T, McGuigan P, Morgan M, Thomas M, Ullen S, Unden J, Nielsen N, Moseby-Knappe M. Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest: Rationale and design of the prospective TTM2-CT-substudy. Resusc Plus. 2022 Oct 12;12:100316. doi: 10.1016/j.resplu.2022.100316. eCollection 2022 Dec. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020520 | Brain Infarction |
| D002561 | Cerebrovascular Disorders |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D009336 | Necrosis |