TBI-Prognosis Multicenter Prospective Study

Study Overview
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Brief Summary
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Severe traumatic brain injury (TBI) is the leading cause of death and disability among people under 45 years of age and a major public health problem. Although management of severe TBI patients has gradually improved with the establishment of intensive care units (ICU) and the development of practice guidelines, mortality is still high - ranging from 30 to 50% - with 30% of survivors suffering from severe neurological sequelae such as neurovegetative states. Families and medical teams are frequently called upon to determine reasonable and appropriate goals of care for brain injured patients. They may have to consider high intensity of care, but also the withdrawal of life-sustaining therapies in accordance with patient wishes. Physicians involved in the care of severe traumatic brain injury have expressed serious concerns about hasty decisions made in the absence of appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a multimodal approach of different prognostic indicators and their evolution over time in the acute phase of care. The results of this study will provide better objective information that will facilitate the shared-decision making-process with families and relatives.

Official Title
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Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Other: Prognostic tests


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (≥ 18 years) with severe blunt TBI admitted to the ICU All patients with a GCS ≤ 8 after initial resuscitation Exclusion Criteria: Anticipated being on mechanical ventilation for < 48 hour period due to an altered level of consciousness related to the TBI plus another potentially reversible factor (i.e. drugs, substance abuse, excessive sedation, etc.). Solid malignancy with a life expectation <12 months Liver cirrhosis Child C Chronic heart failure (NYHA class IV) End-stage chronic respiratory disease (O2 dependent) End-stage renal disease (initiated or expectant chronic dialysis or to be expected) Previous neurologic disorder with abnormal findings (such as a mass lesion) on radiological imaging (CT-scan, MRI) or electrophysiological tests (EEG, SSEP) (such as previous uncontrolled epilepsy, significant stroke, previous or acute concomitant spinal cord injury, etc) Patients with no fixed address will be excluded because of the difficult follow-up Physician refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prognostic evaluation<br>Prognostic tests/exams performed according to a determined schedule during the acute phase of care following admission in the intensive care unit. | Other: Prognostic tests<br>* Brain CT-Scan on day 1, 3 and 7 Brain MRI on day 7 SomatoSensory Evoked Potentials on day 7 Electroencephalogram on day 7 Serum biomarkers on day 1, 3 and 7 Daily clinical exams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glasgow Outcome Scale Extended |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQuol - EQ-5D-5L |  | 12 months | 
| Glasgow Outcome Scale Extended |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traumatic Brain Injury, Critically ill Patients, Death, Head Injury, TBI-Prognosis, Critical Care Medicine, Withdrawal of Life Sustaining Therapy, Prognosis, Prognostic Evaluation, Outcome Research, Mortality, Decision-making