TBI-Prognosis Multicenter Prospective Study

NCT02452541 | Unknown

• 1 other identifier: PEJ-679
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 17

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale Extended

  12 months

Secondary Outcomes (2)

• EuroQuol - EQ-5D-5L

  12 months

• Glasgow Outcome Scale Extended

  6 months

Study Arms (1)

Prognostic evaluation

OTHER

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

Interventions

Prognostic tests 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

Prognostic evaluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years) with severe blunt TBI admitted to the ICU
• All patients with a GCS ≤ 8 after initial resuscitation

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Fonds de la Recherche en Santé du Québec: collaborator
• Canadian Critical Care Trials Group: collaborator

Study Sites (17)

Foothills Health Sciences Centre

Calgary, Alberta, Canada

Location

Capital Health - Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

Capital Health - University Of Alberta Hospital

Edmonton, Alberta, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, Canada

Location

Winnipeg Health Sciences Center

Winnipeg, Manitoba, Canada

Location

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Center

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

ST. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Hôpital Sacré-Coeur de Montréal

Montreal, Quebec, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

CHU de Québec - Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Location

CHU Sherbrooke - Hôpital Fleurimont

Sherbrooke, Quebec, Canada

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Death; Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexis Turgeon, MD MSc FRCPC

  CHU de Quebec Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc FRCPC

Study Record Dates

• First Submitted: May 20, 2015
• First Posted: May 22, 2015
• Study Start: April 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 9, 2016

Record last verified: 2016-06

Locations

CA (17)