Head Computed Tomography for Predicting Neurological Outcome After Cardiac Arrest- a TTM-2 Substudy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Poor functional outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Poor functional outcome
时间窗: 180 days
Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
次要结局
- Exploratory: Neurocognitive outcome(180 days)
- Exploratory: Functional outcome(180 days)