Prediction for Coma Recovery in ICU With Comaweb: a Validation Study
试验速览
- 阶段
- 不适用
- 入组人数
- 611
- 试验地点
- 1
- 主要终点
- The unfavorable outcome
研究概览
简要总结
The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury.
详细描述
The general objective of the comaScore project is to provide an external validation of the accuracy of the comaScore, a score derived from magnetic resonance imaging (MRI), to predict 1 year outcome of patients unresponsive to simple orders after traumatic brain injury (TBI), aneurysmal subarachnoid hemorrhages (aSAH) and cardiac arrest (CA) in the day 7 - day 45 period post brain injury. As recent studies reported late awakeners cases, even in cardiac arrest and, in contrary, that around 10% of patients with acute brain injury remain with permanent disorders of consciousness (DOC), the need of reliable prognosis tool at the early phase, while the patient is still in the ICU, is critical. ComaScore, based on the quantitative analysis of diffusion tensor imaging, was developed from a derivation cohort of 506 patients. It is much more performing than existing tools (IMPACT, OHCA) in this respect.
This study aims to prospectively validate the predictive accuracy of comaScore to predict unfavorable outcome at 1-year after the first insult, in an independent sample (external validation). Unfavorable outcome is defined as a Glascow Outcome Scale Extended (GOSE) of 1 to 3. This scale ranges from 1 to 8. Scores of 1 to 3 correspond to death, vegetative state, minimally conscious state or bedridden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient Inclusion criteria
- •Male or female subject of 18 years old or above
- •Affiliated to a social security system excluding "Aide Médicale d'État (AME)"
- •Hospitalized in an intensive care unit and requiring mechanical ventilation after TBI, aSAH or CA
- •Absence of response to simple orders not explained by sedation alone at inclusion
- •Patient within 7 to 45 days after onset of TBI, aSAH or CA
- •Scheduled MRI within 5 days after inclusion
- •Written informed consent to participate in the study must be obtained proxy/legal representative.
- •Patient non-inclusion criteria
- •MRI unavailability between day 7 and day 45 after brain injury
- •Origin of coma other than CA, TBI or aSAH
- •Pre-existing serious brain disease prior to coma status
- •Contra-indication to perform MRI
- •Subject protected by the law (curatorship or tutorship)
- •Patient secondary
排除标准
- •Consciousness recovery before MRI exam
- •Contra-indication to perform MRI (appeared / discovered after inclusion)
- •Healthy controls Inclusion criteria
- •Male or female subject from 18 to 65 years
- •Affiliated to a social security system excluding "Aide Médicale d'État (AME)".
- •No history of previous brain disease
- •No contra-indication to perform an MRI.
- •No pregnancy
- •Voluntarily agrees to participate by providing written informed consent
- •Healthy controls Non-Inclusion criteria
- •Subject protected by the law (curatorship or tutorship)"
研究组 & 干预措施
Patient group
To assess the predictive accuracy of comaScore evaluated in the day 7 - day 45 period post brain injury to predict unfavorable outcome at 1-year after the first insult in patients admitted in ICU after CA, TBI and aSAH, that remain comatose at least 7 days after brain injury.
干预措施: MRI sequence (Other)
Test group
MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences
干预措施: MRI (Other)
结局指标
主要结局
The unfavorable outcome
时间窗: 1 year after the initial brain injury
The unfavorable outcome is defined as a Glascow Outcome Scale Extended (GOSE) of 1 to 3. This scale ranges from 1 to 8. Scores of 1 to 3 correspond to death, vegetative state, minimally conscious state or bedridden.
次要结局
- Etiology-specific performances of the Comascore evaluation after traumatic brain injury(1 year after the initial brain injury)
- Comparison between COMASCORE and OHCA score after cardiac arrest(1 year after the initial brain injury)
- Comparison between COMASCORE and IMPACT score after traumatic brain injury(1 year after the initial brain injury)
- Time-window-specific performances of the Comascore evaluation(day 7 to 15, day 16 to 25, day 26 to 35 or day 36 to 45)
- Etiology-specific performances of the Comascore evaluation after cardiac arrest(1 year after the initial brain injury)
- Etiology-specific performances of the Comascore evaluation after aneurysmal subarachnoid hemorrhages(1 year after the initial brain injury)
- Comparison between COMASCORE and WFNS score after aneurysmal subarachnoid hemorrhages(1 year after the initial brain injury)