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Clinical Trials/NCT03874208
NCT03874208UnknownNot Applicable

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

Assistance Publique - Hôpitaux de Paris2 sites in 1 country611 target enrollmentStarted: January 15, 2020Last updated:
Conditions

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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