MedTrace Logo

TBI-Prognosis Multicenter Prospective Study

NCT02452541 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2016-06-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Canadian Critical Care Trials Group

    collaborator OTHER

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Alexis Turgeon, MD MSc FRCPC · CHU de Quebec Research Center

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2017-02-28
Completion
2017-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02452541 on ClinicalTrials.gov