Observing brain biomarkers in severe traumatic brain injury
Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial (BioBOOST)
This study is trying to see how changes in brain markers relate to the severity of brain injuries and recovery in people with severe traumatic brain injuries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Ann Arbor, Michigan and 1 other locations) |
| Trial ID | NCT04565119 on ClinicalTrials.gov |
What this trial studies
This observational study, known as BioBOOST, investigates the relationship between brain physiological parameters and biomarker levels in patients with severe traumatic brain injury. It is a multicenter study that collects biospecimens shortly after injury and at various intervals to analyze acute and sub-acute changes in biomarker levels. The study utilizes data from the BOOST-3 trial, which focuses on goal-directed critical care based on brain tissue oxygen monitoring. The aim is to better understand how these biomarkers correlate with brain injury severity and recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are enrolled in the BOOST-3 trial and can provide proxy informed consent.
Not a fit: Patients who are profoundly anemic or those under the age of 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of brain injury biomarkers, potentially leading to improved treatment strategies for patients with severe traumatic brain injury.
How similar studies have performed: Other studies have shown promise in utilizing biomarkers for understanding traumatic brain injury, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrolled in BOOST-3 (this is an ancillary study to the BOOST-3 trial) * BOOST-3 participant is enrolled at a BioBOOST site * Able to maintain initial blood sample within 24 hours of injury * Provide proxy informed consent Exclusion Criteria: * Profoundly anemic (subjects who are profoundly anemic require blood transfusion) * Age less than 18 years
Where this trial is running
Ann Arbor, Michigan and 1 other locations
- University of Michigan — Ann Arbor, Michigan, United States (Not_yet_recruiting)
- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Ramon Diaz-Arrastia, MD, PhD
- Email: Ramon.Diaz-Arrastia@pennmedicine.upenn.edu
- Phone: 215-662-9732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.