Brain Injury, ComaCOMASCORENCT03874208
Prediction for Coma Recovery With Comaweb
A study testing MRI sequence and MRI in people with Brain Injury, Coma and Cardiac Arrest (CA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injury, Coma, Cardiac Arrest (CA), Traumatic Brain Injury (TBI)
- What is being tested?
- MRI sequence and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
- Subject protected by the law (curatorship or tutorship)"
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Saint-Jean
Perpignan, 66000
SMADJA Philippe, MD
DURAND Pierre-Guy, MD
About this study
Official title: 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.
Read the 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)
- Being tested
- MRI sequence, MRI
- Keywords
- Outcome prediction, Disorders of Consciousness, Coma,, MRI, Brain injury
- Medical subject headings
- Brain Injuries, Coma, Heart Arrest, Brain Injuries, Traumatic, Subarachnoid Hemorrhage, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI sequenceOther
An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used).
MRIOther
MRI exam
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI sequence |
| Test group | Other | MRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year after the initial brain injury
Secondary outcomes (7)
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
Measured: 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."
Measured: 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."
Measured: 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."
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after the initial brain injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start15 Jan 2020
- Primary completionMar 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, ComaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 611 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Puybasset Louis, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874208
- Sponsor's protocol ID
- D20180112
- Other IDs
- 2018-A02190-55
- Acronym
- COMASCORE
- Status last verified
- Feb 2019
- First submitted
- 12 Mar 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction for Coma Recovery in ICU With Comaweb: a Validation Study
- ClinicalTrials.gov ID
- NCT03874208
- Acronym / sponsor ID
- COMASCORE / D20180112
- Conditions
- Brain Injury, Coma, Cardiac Arrest (CA), Traumatic Brain Injury (TBI), Aneurysmal Subarachnoid Hemorrhages (aSAH)
- Keywords
- Outcome prediction, Disorders of Consciousness, Coma,, MRI, Brain injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 611 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | Other | Other: MRI sequenceTo 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. |
| Test group | Other | Other: MRIMRI calibration in each center : test protocol compliance, data transfer procedures and quality of the MRI sequences |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI sequenceAn additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used). | Other | Patient group |
| MRIMRI exam | Other | Test group |
Primary outcome
The unfavorable outcome
Time frame: 1 year after the initial brain injury
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.
7 secondary outcomes
Time-window-specific performances of the Comascore evaluation
Time frame: 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
Time frame: 1 year after the initial brain injury
Etiology-specific performances of the Comascore evaluation after traumatic brain injury
Time frame: 1 year after the initial brain injury
Etiology-specific performances of the Comascore evaluation after aneurysmal subarachnoid hemorrhages
Time frame: 1 year after the initial brain injury
Comparison between COMASCORE and OHCA score after cardiac arrest
Time frame: 1 year after the initial brain injury
Comparison between COMASCORE and IMPACT score after traumatic brain injury
Time frame: 1 year after the initial brain injury
Comparison between COMASCORE and WFNS score after aneurysmal subarachnoid hemorrhages
Time frame: 1 year after the initial brain injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Puybasset Louis, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI sequence and MRI in people with Brain Injury, Coma and Cardiac Arrest (CA), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis, MD (1 42 16 33 85 ext. 0033, louis.puybasset@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The unfavorable outcome (time frame: 1 year after the initial brain injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.