TBI-Prognosis Multicenter Prospective Study

June 7, 2016 updated by: Alexis Turgeon, CHU de Quebec-Universite Laval

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Health Sciences Centre
      • Edmonton, Alberta, Canada
        • Capital Health - Royal Alexandra Hospital
      • Edmonton, Alberta, Canada
        • Capital Health - University of Alberta Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada
        • Royal Columbian Hospital
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
      • Victoria, British Columbia, Canada
        • Royal Jubilee Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Winnipeg Health Sciences Center
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Queen Elizabeth Ii Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences Center
      • London, Ontario, Canada
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
      • Toronto, Ontario, Canada
        • St. Michael's Hospital
      • Toronto, Ontario, Canada
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Montreal General Hospital
      • Montréal, Quebec, Canada
        • Hopital Sacre-Coeur de Montreal
      • Québec, Quebec, Canada
        • CHU de Quebec - Hopital de l'Enfant-Jesus
      • Sherbrooke, Quebec, Canada
        • CHU Sherbrooke - Hôpital Fleurimont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prognostic evaluation
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
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glasgow Outcome Scale Extended
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Canadian Critical Care Trials Group

Investigators

  • Principal Investigator: Alexis Turgeon, MD MSc FRCPC, CHU de Quebec Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEJ-679

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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