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临床试验/NCT03874208
NCT03874208Unknown不适用

Prediction for Coma Recovery in ICU With Comaweb: a Validation Study

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 611 人开始时间: 2020年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
611
试验地点
2
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

入选标准

  • 未提供

排除标准

  • 未提供

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 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)
  • 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 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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