TBI-Prognosis Multicenter Prospective Study

Not Applicable

• Conditions: Traumatic Brain Injury
• Interventions: Other: Prognostic tests

• Registration Number: NCT02452541
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-22
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-07
• Last Update Posted: 2016-06-09
• Primary Completion: 2017-02
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 315

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prognostic evaluation	Prognostic tests	Prognostic tests/exams performed according to a determined schedule during the acute phase of care following admission in the intensive care unit.

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale Extended	12 months

Secondary Outcome Measures

Name	Time	Method
EuroQuol - EQ-5D-5L	12 months
Glasgow Outcome Scale Extended	6 months

Trial Locations

Locations (17)

Capital Health - Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

Foothills Health Sciences Centre; 🇨🇦 Calgary, Alberta, Canada

Capital Health - University Of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada

CHU de Québec - Hôpital de l'Enfant-Jésus; 🇨🇦 Québec, Quebec, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

CHU Sherbrooke - Hôpital Fleurimont; 🇨🇦 Sherbrooke, Quebec, Canada

Winnipeg Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Hamilton Health Sciences Center; 🇨🇦 Hamilton, Ontario, Canada

ST. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada

Hôpital Sacré-Coeur de Montréal; 🇨🇦 Montréal, Quebec, Canada

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada