PREdiction and Diagnosis using Imaging and Clinical biomarkers Trial in Traumatic Brain Injury

Not Applicable

Recruiting

• Conditions: Traumatic Brain Injury; Injuries and Accidents - Other injuries and accidents; Neurological - Other neurological disorders

• Registration Number: ACTRN12620001360909
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-17
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1.Age greater than or equal to 18 years old
2.Diagnosed with moderate or severe TBI*, with or without other injuries.
*TBI Definition - A TBI will be defined based on the post-resuscitation Glasgow Coma Scale (GCS) in the pre-hospital period and the first 24 hours of ICU admission, if admitted to ICU. Moderate and Severe TBI are defined by the following categories of GCS if in the opinion of the treating team GCS is not solely due to intoxication, sedation, or extracranial injury
•Moderate TBI is defined as a GCS score of 9-12
•Severe TBI is defined as a GCS score of less than or equal to 8

Exclusion Criteria

1. Previous major stroke
2. Pregnancy, or may be pregnant
3. In the opinion of the investigator the participant would be unlikely to be able to comply with study procedures and follow up (e.g. lives overseas).
4. Presence of underlying disease with a life expectancy of less than 6 months
5. Known contraindication to MRI that will prevent study procedures
6. Patients who have suffered a devastating TBI with either progression towards brain death at the time of assessment or where the treating medical team are not committed to ongoing full supportive care
7. Traumatic brain injury occurred more than 72 hours ago

Study & Design

• Study Type: Observational
• Study Design: Not specified