NCT03874208

Prediction for Coma Recovery With Comaweb

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 611 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Brain Injury, Coma
• Cardiac Arrest (CA)
• Traumatic Brain Injury (TBI)
• Aneurysmal Subarachnoid Hemorrhages (aSAH)

Interventions

Type	Name	Description
OTHER	MRI sequence	An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used).
OTHER	MRI	MRI exam

Timeline

• Start date: 2020-01-15
• Primary completion: 2022-03-01
• Completion: 2022-09-01
• First posted: 2019-03-14
• Last updated: 2020-01-28

Locations

1 site across 1 country: France