Prediction for Coma Recovery With Comaweb

NCT03874208 | Unknown

• 2 other identifiers: D201801122018-A02190-55
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Time-window-specific performances of the Comascore evaluation

  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

  1 year after the initial brain injury

• Etiology-specific performances of the Comascore evaluation after traumatic brain injury

  1 year after the initial brain injury

• Etiology-specific performances of the Comascore evaluation after aneurysmal subarachnoid hemorrhages

  1 year after the initial brain injury

• Comparison between COMASCORE and OHCA score after cardiac arrest

  1 year after the initial brain injury

Study Arms (2)

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.

Other: MRI sequence

Test group

OTHER

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

Other: MRI

Interventions

MRI sequence OTHER

An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used).

Patient group

MRI OTHER

MRI exam

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient within 7 to 45 days after onset of TBI, aSAH or CA
• Written informed consent to participate in the study must be obtained proxy/legal representative.
• 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)

You may not qualify if:

• Consciousness recovery before MRI exam
• 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
• \. Subject protected by the law (curatorship or tutorship)"

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Centre Hospitalier Saint-Jean

Perpignan, 66000, France

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Coma; Heart Arrest; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Consciousness Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Hemorrhage; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Study Officials

• Puybasset Louis, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: January 15, 2020
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 28, 2020

Record last verified: 2019-02

Locations

FR (1)