Prediction for Coma Recovery With Comaweb (COMASCORE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Brain Injury, Coma; Cardiac Arrest (CA); Traumatic Brain Injury (TBI); Aneurysmal Subarachnoid Hemorrhages (aSAH)
• Intervention / Treatment: Other: MRI sequence; Other: MRI

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 Type: Interventional
• Enrollment (Anticipated): 611
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Perpignan, France, 66000
    • Recruiting
    • Centre Hospitalier Saint-Jean
    • Contact: SMADJA Philippe, MD
    • Contact: DURAND Pierre-Guy, MD
    • Principal Investigator: DURAND Pierre-Guy, MD
    • Principal Investigator: SMADJA Philippe, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)"

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient group; 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.	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: Test group; MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences	Other: MRI; MRI exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	" 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Puybasset Louis, MD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Brain injury; Outcome prediction; Disorders of Consciousness; Coma,
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Unconsciousness; Consciousness Disorders; Intracranial Hemorrhages; Brain Injuries; Wounds and Injuries; Hemorrhage; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Coma
• Other Study ID Numbers: D20180112; 2018-A02190-55 (Other Identifier: IDRCB number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No