TBI-Prognosis Multicenter Prospective Study

NCT ID: NCT02452541

Last Updated: 2016-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Prognostic evaluation

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

Group Type: OTHER

Prognostic tests

Intervention Type: OTHER

• 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

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Canadian Critical Care Trials Group

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Alexis Turgeon

MD MSc FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexis Turgeon, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

CHU de Quebec Research Center

Locations

Foothills Health Sciences Centre

Calgary, Alberta, Canada

Capital Health - Royal Alexandra Hospital

Edmonton, Alberta, Canada

Capital Health - University Of Alberta Hospital

Edmonton, Alberta, Canada

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

ST. Michael's Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Montreal General Hospital

Montreal, Quebec, Canada

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

CHU Sherbrooke - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

PEJ-679

Identifier Type: -

Identifier Source: org_study_id