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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02452541
Other study ID # PEJ-679
Secondary ID
Status Active, not recruiting
Phase N/A
First received May 20, 2015
Last updated June 7, 2016
Start date April 2013
Est. completion date September 2017

Study information

Verified date June 2016
Source Centre Hospitalier Universitaire de Québec, CHU de Québec
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 315
Est. completion date September 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Foothills Health Sciences Centre Calgary Alberta
Canada Capital Health - Royal Alexandra Hospital Edmonton Alberta
Canada Capital Health - University Of Alberta Hospital Edmonton Alberta
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 Montreal General Hospital Montreal Quebec
Canada Hôpital Sacré-Coeur de Montréal Montréal Quebec
Canada Royal Columbian Hospital New Westminster British Columbia
Canada The Ottawa Hospital Ottawa Ontario
Canada CHU de Québec - Hôpital de l'Enfant-Jésus Québec Quebec
Canada CHU Sherbrooke - Hôpital Fleurimont Sherbrooke Quebec
Canada ST. Michael's Hospital Toronto Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada Vancouver General Hospital Vancouver British Columbia
Canada Royal Jubilee Hospital Victoria British Columbia
Canada Winnipeg Health Sciences Center Winnipeg Manitoba

Sponsors (4)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Québec, CHU de Québec Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glasgow Outcome Scale Extended 12 months No
Secondary EuroQuol - EQ-5D-5L 12 months No
Secondary Glasgow Outcome Scale Extended 6 months No
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