NCT03874208 - Prediction for Coma Recovery With Comaweb | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

611

Conditions

Brain Injury, Coma Cardiac Arrest (CA)Traumatic Brain Injury (TBI)Aneurysmal Subarachnoid Hemorrhages (aSAH)

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)"

Locations (1)

Centre Hospitalier Saint-Jean

Perpignan, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 year after the initial brain injury

Secondary Outcomes

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

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

" 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

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."

Time frame: 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."

Central Contacts

Louis, MD

CONTACT

1 42 16 33 85 louis.puybasset@aphp.fr

PUYBASSET Louis, MD

CONTACT

1 42 16 33 85 louis.puybasset@aphp.fr