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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02190-55 | Other Identifier | IDRCB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Other | 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. |
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| Test group | Other | MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI sequence | Other | An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used). |
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| Measure | Description | Time Frame |
|---|---|---|
| The unfavorable outcome | 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. | 1 year after the initial brain injury |
| Measure | Description | Time Frame |
|---|---|---|
| Time-window-specific performances of the Comascore evaluation | To assess the impact of time from brain injury to MRI allowing to calculate comaScore on the predictive accuracy of comaScore (4 periods will be determined | 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 |
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Patient Inclusion criteria
Patient non-inclusion criteria
Patient secondary exclusion criteria
Healthy controls Inclusion criteria
Healthy controls Non-Inclusion criteria
1. Subject protected by the law (curatorship or tutorship)"
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis, MD | Contact | 1 42 16 33 85 | 0033 | louis.puybasset@aphp.fr |
| PUYBASSET Louis, MD | Contact | 1 42 16 33 85 | 0033 | louis.puybasset@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Puybasset Louis, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Saint-Jean | Recruiting | Perpignan | 66000 | France |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D003128 | Coma |
| D006323 | Heart Arrest |
| D000070642 | Brain Injuries, Traumatic |
| D013345 | Subarachnoid Hemorrhage |
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| MRI | Other | MRI exam |
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" 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 or TBI or sSAH, that remain unresponsive to simple orders at least 7 days after brain injury." |
| 1 year after the initial brain injury |
| Etiology-specific performances of the Comascore evaluation after traumatic brain injury | " 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 or TBI or sSAH, that remain unresponsive to simple orders at least 7 days after brain injury." | 1 year after the initial brain injury |
| Etiology-specific performances of the Comascore evaluation after aneurysmal subarachnoid hemorrhages | " 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 or TBI or sSAH, that remain unresponsive to simple orders at least 7 days after brain injury." | 1 year after the initial brain injury |
| Comparison between COMASCORE and OHCA score after cardiac arrest | To test the statistical difference in predictive accuracy between comaScore evaluated in the day 7 - day 45 period post brain injury and OHCA or IMPACT or WFNS score to predict unfavorable outcome at 1-year after the first insult in patients admitted in ICU after CA or TBI or aSAH, respectively, that remain unresponsive to simple orders at least 7 days after brain injury. | 1 year after the initial brain injury |
| Comparison between COMASCORE and IMPACT score after traumatic brain injury | To test the statistical difference in predictive accuracy between comaScore evaluated in the day 7 - day 45 period post brain injury and OHCA or IMPACT or WFNS score to predict unfavorable outcome at 1-year after the first insult in patients admitted in ICU after CA or TBI or aSAH, respectively, that remain unresponsive to simple orders at least 7 days after brain injury. | 1 year after the initial brain injury |
| Comparison between COMASCORE and WFNS score after aneurysmal subarachnoid hemorrhages | To test the statistical difference in predictive accuracy between comaScore evaluated in the day 7 - day 45 period post brain injury and OHCA or IMPACT or WFNS score to predict unfavorable outcome at 1-year after the first insult in patients admitted in ICU after CA or TBI or aSAH, respectively, that remain unresponsive to simple orders at least 7 days after brain injury. | 1 year after the initial brain injury |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014474 | Unconsciousness |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |