Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatment prognostic tests
Sponsor Centre Hospitalier Universitaire de Québec, CHU de Québec
Collaborator Canadian Institutes of Health Research (CIHR)
Start date April 2013
End date February 2017
Trial size 315 participants
Trial identifier NCT02452541, PEJ-679

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(Other)
Prognostic tests/exams performed according to a determined schedule during the acute phase of care following admission in the intensive care unit.
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 Outcomes

Measure
Glasgow Outcome Scale Extended
time frame: 12 months

Secondary Outcomes

Measure
EuroQuol - EQ-5D-5L
time frame: 12 months
Glasgow Outcome Scale Extended
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study
Principal investigator Alexis Turgeon, MD MSc FRCPC
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Québec, CHU de Québec.