Prediction for Coma Recovery in ICU With Comaweb: a Validation Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 611
- Locations
- 2
- Primary Endpoint
- The unfavorable outcome
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The unfavorable outcome
Time Frame: 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.
Secondary Outcomes
- 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)
