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Traumatic Brain InjuryNCT02452541

TBI-Prognosis Multicenter Prospective Study

A study testing Prognostic tests in people with Traumatic Brain Injury, run by CHU de Quebec-Universite Laval at 17 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Prognostic tests
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
17 sitesCanada
Study dates
Apr 2013to Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Canada17 sites

  • Foothills Health Sciences Centre

    Calgary, Alberta

  • Capital Health - Royal Alexandra Hospital

    Edmonton, Alberta

  • Capital Health - University Of Alberta Hospital

    Edmonton, Alberta

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia

  • Hamilton Health Sciences Center

    Hamilton, Ontario

  • London Health Sciences Centre

    London, Ontario

  • Hôpital Sacré-Coeur de Montréal

    Montreal, Quebec

  • Montreal General Hospital

    Montreal, Quebec

  • Royal Columbian Hospital

    New Westminster, British Columbia

  • The Ottawa Hospital

    Ottawa, Ontario

  • CHU de Québec - Hôpital de l'Enfant-Jésus

    Québec, Quebec

  • CHU Sherbrooke - Hôpital Fleurimont

    Sherbrooke, Quebec

  • ST. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia

  • Royal Jubilee Hospital

    Victoria, British Columbia

  • Winnipeg Health Sciences Center

    Winnipeg, Manitoba

Other trials in Canada

About this study

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

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.

Being tested
Prognostic tests
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
Medical subject headings
Brain Injuries, Traumatic, Death, Craniocerebral Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prognostic testsOther

    • 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
Study groups in NCT02452541
Study groupRoleWhat they receive
Prognostic evaluationOtherPrognostic tests/exams performed according to a determined schedule during the acute phase of care following admission in the intensive care unit.
Receives: Other: Prognostic tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glasgow Outcome Scale Extended

    Measured: 12 months

Secondary outcomes (2)

  1. EuroQuol - EQ-5D-5L

    Measured: 12 months

  2. Glasgow Outcome Scale Extended

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startApr 2013
  3. Primary completionFeb 2017 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452541
Sponsor's protocol ID
PEJ-679
Status last verified
Jun 2016
First submitted
20 May 2015
Last updated
9 Jun 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Prognostic tests in people with Traumatic Brain Injury, run by CHU de Quebec-Universite Laval at 17 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glasgow Outcome Scale Extended (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02452541.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.

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