NCT02452541

TBI-Prognosis Multicenter Prospective Study

Early Determination of Neurological Prognosis in ICU Patients With Severe Traumatic Brain Injury: The TBI-Prognosis Multicenter Prospective Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-01
• Primary completion: 2017-02-01
• Completion: 2017-09-01
• First posted: 2015-05-22
• Last updated: 2016-06-09

Locations

17 sites across 1 country: Canada