Prediction for Coma Recovery With Comaweb

Traumatic Brain Injury (TBI) Clinical Trial

— COMASCORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03874208
• Other study ID #: D20180112
• Secondary ID: 2018-A02190-55
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: September 2022

Study information

• Verified date: February 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Louis, MD
• Phone: 1 42 16 33 85
• Email: louis.puybasset[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 611
• Est. completion date: September 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion criteria

1. Male or female subject of 18 years old or above

2. Affiliated to a social security system excluding "Aide Médicale d'État (AME)"

3. Hospitalized in an intensive care unit and requiring mechanical ventilation after TBI, aSAH or CA

4. Absence of response to simple orders not explained by sedation alone at inclusion

5. Patient within 7 to 45 days after onset of TBI, aSAH or CA

6. Scheduled MRI within 5 days after inclusion

7. Written informed consent to participate in the study must be obtained proxy/legal representative.

Patient non-inclusion criteria

1. MRI unavailability between day 7 and day 45 after brain injury

2. Origin of coma other than CA, TBI or aSAH

3. Pre-existing serious brain disease prior to coma status

4. Contra-indication to perform MRI

5. Subject protected by the law (curatorship or tutorship)

Patient secondary exclusion criteria

1. Consciousness recovery before MRI exam

2. Contra-indication to perform MRI (appeared / discovered after inclusion)

Healthy controls Inclusion criteria

1. Male or female subject from 18 to 65 years

2. Affiliated to a social security system excluding "Aide Médicale d'État (AME)".

3. No history of previous brain disease

4. No contra-indication to perform an MRI.

5. No pregnancy

6. Voluntarily agrees to participate by providing written informed consent

Healthy controls Non-Inclusion criteria

1. Subject protected by the law (curatorship or tutorship)"

Related Conditions & MeSH terms

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

Intervention

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).
• MRI
MRI exam

Locations

Country	Name	City	State
France	Centre Hospitalier Saint-Jean	Perpignan

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Etiology-specific performances of the Comascore evaluation after cardiac arrest	" 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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