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Prediction for Coma Recovery With Comaweb (COMASCORE)

Primary Purpose

Brain Injury, Coma, Cardiac Arrest (CA), Traumatic Brain Injury (TBI)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI sequence
MRI
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Injury, Coma focused on measuring Outcome prediction, Disorders of Consciousness, Coma,, MRI, Brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)"

Sites / Locations

  • Centre Hospitalier Saint-JeanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient group

Test group

Arm Description

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.

MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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."
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."
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."
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.
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.
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.

Full Information

First Posted
March 12, 2019
Last Updated
January 27, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT03874208
Brief Title
Prediction for Coma Recovery With Comaweb
Acronym
COMASCORE
Official Title
Prediction for Coma Recovery in ICU With Comaweb: a Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury, Coma, Cardiac Arrest (CA), Traumatic Brain Injury (TBI), Aneurysmal Subarachnoid Hemorrhages (aSAH)
Keywords
Outcome prediction, Disorders of Consciousness, Coma,, MRI, Brain injury

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
611 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient group
Arm Type
Other
Arm Description
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.
Arm Title
Test group
Arm Type
Other
Arm Description
MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences
Intervention Type
Other
Intervention Name(s)
MRI sequence
Intervention Description
An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used).
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI exam
Primary Outcome Measure Information:
Title
The unfavorable outcome
Description
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.
Time Frame
1 year after the initial brain injury
Secondary Outcome Measure Information:
Title
Time-window-specific performances of the Comascore evaluation
Description
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
Time Frame
day 7 to 15, day 16 to 25, day 26 to 35 or day 36 to 45
Title
Etiology-specific performances of the Comascore evaluation after cardiac arrest
Description
" 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."
Time Frame
1 year after the initial brain injury
Title
Etiology-specific performances of the Comascore evaluation after traumatic brain injury
Description
" 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."
Time Frame
1 year after the initial brain injury
Title
Etiology-specific performances of the Comascore evaluation after aneurysmal subarachnoid hemorrhages
Description
" 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."
Time Frame
1 year after the initial brain injury
Title
Comparison between COMASCORE and OHCA score after cardiac arrest
Description
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.
Time Frame
1 year after the initial brain injury
Title
Comparison between COMASCORE and IMPACT score after traumatic brain injury
Description
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.
Time Frame
1 year after the initial brain injury
Title
Comparison between COMASCORE and WFNS score after aneurysmal subarachnoid hemorrhages
Description
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.
Time Frame
1 year after the initial brain injury

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patient Inclusion criteria Male or female subject of 18 years old or above Affiliated to a social security system excluding "Aide Médicale d'État (AME)" Hospitalized in an intensive care unit and requiring mechanical ventilation after TBI, aSAH or CA Absence of response to simple orders not explained by sedation alone at inclusion Patient within 7 to 45 days after onset of TBI, aSAH or CA Scheduled MRI within 5 days after inclusion Written informed consent to participate in the study must be obtained proxy/legal representative. Patient non-inclusion criteria MRI unavailability between day 7 and day 45 after brain injury Origin of coma other than CA, TBI or aSAH Pre-existing serious brain disease prior to coma status Contra-indication to perform MRI Subject protected by the law (curatorship or tutorship) Patient secondary exclusion criteria Consciousness recovery before MRI exam Contra-indication to perform MRI (appeared / discovered after inclusion) Healthy controls Inclusion criteria Male or female subject from 18 to 65 years Affiliated to a social security system excluding "Aide Médicale d'État (AME)". No history of previous brain disease No contra-indication to perform an MRI. No pregnancy Voluntarily agrees to participate by providing written informed consent Healthy controls Non-Inclusion criteria 1. Subject protected by the law (curatorship or tutorship)"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louis, MD
Phone
1 42 16 33 85
Ext
0033
Email
louis.puybasset@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
PUYBASSET Louis, MD
Phone
1 42 16 33 85
Ext
0033
Email
louis.puybasset@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Puybasset Louis, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Saint-Jean
City
Perpignan
ZIP/Postal Code
66000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SMADJA Philippe, MD
First Name & Middle Initial & Last Name & Degree
DURAND Pierre-Guy, MD
First Name & Middle Initial & Last Name & Degree
DURAND Pierre-Guy, MD
First Name & Middle Initial & Last Name & Degree
SMADJA Philippe, MD

12. IPD Sharing Statement

Learn more about this trial

Prediction for Coma Recovery With Comaweb

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