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Clinical Trials/NCT02452541
NCT02452541
Unknown
Not Applicable

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

CHU de Quebec-Universite Laval17 sites in 1 country315 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
CHU de Quebec-Universite Laval
Enrollment
315
Locations
17
Primary Endpoint
Glasgow Outcome Scale Extended
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
September 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
CHU de Quebec-Universite Laval
Responsible Party
Principal Investigator
Principal Investigator

Alexis Turgeon

MD MSc FRCPC

CHU de Quebec-Universite Laval

Eligibility Criteria

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

Outcomes

Primary Outcomes

Glasgow Outcome Scale Extended

Time Frame: 12 months

Secondary Outcomes

  • EuroQuol - EQ-5D-5L(12 months)
  • Glasgow Outcome Scale Extended(6 months)

Study Sites (17)

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