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TBI-Prognosis Multicenter Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452541
Recruitment Status : Unknown
Verified June 2016 by Alexis Turgeon, CHU de Quebec-Universite Laval.
Recruitment status was:  Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : June 9, 2016
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Canadian Critical Care Trials Group
Information provided by (Responsible Party):
Alexis Turgeon, CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Other: Prognostic tests Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study
Study Start Date : April 2013
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Glasgow Outcome Scale Extended [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. EuroQuol - EQ-5D-5L [ Time Frame: 12 months ]
  2. Glasgow Outcome Scale Extended [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452541


Locations
Show Show 17 study locations
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Canadian Critical Care Trials Group
Investigators
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Principal Investigator: Alexis Turgeon, MD MSc FRCPC CHU de Quebec Research Center
Additional Information:
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Responsible Party: Alexis Turgeon, MD MSc FRCPC, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02452541    
Other Study ID Numbers: PEJ-679
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Keywords provided by Alexis Turgeon, CHU de Quebec-Universite Laval:
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
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System