PRECISION-TBI - An Observational Study of Patients With Moderate to Severe Traumatic Brain Injury

ConditionTrauma, Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAustralian and New Zealand Intensive Care Research Centre

About this trial

Traumatic Brain Injury (TBI) is a devastating condition and a leading cause of long-term disability. Every patient with TBI has a different type of injury and is treated differently from hospital to hospital making it very difficult to identify the most effective treatments. The current study focuses on the most severe types of TBI that require hospital ICU care - moderate to severe TBI (m-sTBI). The overall aim of this study is to collect data about how different hospitals manage m-sTBI in Australia, and to quantify the variability that likely exists. Recovery at 6 months post-injury will be collected to allow a better understanding on how different injuries and treatments affect long term outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Clinical diagnosis of moderate to severe TBI

Insertion of invasive intra-cranial monitoring

Study inclusion within 48 hours of ICU admission

Disqualifiers

Admission to the ICU is solely for the purposes of palliative care or confirmation of organ donation

Advanced care directive or previously stated wish not to be included in research activities

Trial population

moderate to severe traumatic brain injured patients who are admitted to the intensive care unit.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Glasgow outcome scale

Unfavourable outcome at 6 months post-injury (defined as a score of 4 or less on the 8-point extended Glasgow outcome scale)

Time frame
At 6 months post-injury

Secondary outcomes

1

Mortality

Death occurring any time between date of hospital admission and 6 months post-injury (up to 180 days post-injury)

Time frame
Up to 6 months post-injury
2

Hospital length of stay

Number of acute hospital admission days

Time frame
Through study completion, an average of 1 year
3

Intensive care Unit (ICU) length of stay

Number of ICU admission days

Time frame
Through study completion, an average of 1 year
4

EuroQol (EQ-5D five-level)

Quality of life questionnaire, each of the 5 questions is scored from 1 (no problem performing that particular task) to 5 (unable to perform the task).

Time frame
At 6 months post-injury

Other outcomes

Sponsors and contacts

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