- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04565119
Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial (BioBOOST)
Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial (BioBOOST)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective observational, multi-center study of subjects enrolled in the Brain Oxygen Optimization in Severe Traumatic Brain Injury-Phase 3 (BOOST-3) trial. BOOST-3 is a multicenter, randomized, blinded-endpoint, comparative effectiveness study of goal-directed critical care based upon monitoring of brain tissue oxygen and intracranial pressure versus monitoring of intracranial pressure alone in patients with severe traumatic brain injury.
The investigators will obtain an initial set of biospecimens (serum, plasma, cerebrospinal fluid (CSF), DNA and RNA) shortly after randomization into BOOST-3 and within 24 hours of injury. Subsequent biospecimens will be obtained every 8 hours for the first 24 hours post-enrollment. This will allow the characterization of acute changes in biomarker levels. On study days 2 through 5, biospecimens will be obtained twice a day to allow characterization of sub-acute changes in biomarker levels, without overburdening study teams or taking too much blood from individual subjects. On study days 7 and 14 and at 6-months post-enrollment, one set of biospecimen will be obtained, preferably in the morning. Biospecimens collected at each time point will consist of 6 ml of whole blood for serum extraction, 6 ml of whole blood for plasma extraction, 2.5 ml of whole blood for RNA extraction (a total of 14.5 ml [one tablespoon] of blood) and 5 ml of cerebrospinal fluid (CSF).
BioBOOST will utilize data collected in the BOOST-3 trial. This data includes: demographic data and clinical data such as injury characteristics, vital signs, head CT findings, laboratory data and data on physiologic parameters such as intracranial pressure (ICP), partial pressure of brain tissue oxygen (PbtO2), mean arterial pressure (MAP), and cerebral perfusion pressure (CPP), among others.
BioBOOST will also utilize outcome assessment data collected from BOOST-3 participants at 6 months after injury (180 Days ± 30 days). Trained study personnel who are blinded to the treatment arm will administer the outcome assessments, which will include the measures listed below. The battery includes measures of functional status (GOSE), cognition, and emotional health. The 6-month follow-up interview will be done in person whenever possible. It may be done by telephone or video conference with participants where an in-person interview is not possible.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ramon Diaz-Arrastia, MD, PhD
- Phone Number: 215-662-9732
- Email: Ramon.Diaz-Arrastia@pennmedicine.upenn.edu
Study Contact Backup
- Name: Cynthia Diaczynsky
- Email: cynthia.diaczynsky@pennmedicine.upenn.edu
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Not yet recruiting
- University of Michigan
-
Contact:
- Fred Korley, MD, PhD
- Email: korley@med.umich.edu
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Penn Presbyterian Medical Center
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Contact:
- Ramon Diaz-Arrastia, MD, PhD
- Phone Number: 800-789-7366
- Email: Ramon.Diaz-Arrastia@pennmedicine.upenn.edu
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Principal Investigator:
- Ramon Diaz-Arrastia, MD, PhD
-
Sub-Investigator:
- Danielle Sandsmark, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Severe traumatic brain injury (TBI)
This observational study is ancillary to the Brain Oxygen Optimization in Severe TBI Phase 3 (BOOST-3) trial (NCT 03754114).
All participants in Bio-BOOST are enrolled in BOOST-3.
|
There are no interventions being tested in the Bio-BOOST study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak levels of glial fibrillary acidic protein (GFAP)
Time Frame: First 5 days after injury
|
This hypothesis will be tested via linear regression model, with peak GFAP level as the response variable and hypoxia exposure as the predictor of interest.
Hypoxia exposure will be defined as the depth and duration of PbtO2 < 20 mmHg during the first 48 hours of injury, quantified using area under the curve (AUC) methodology.
|
First 5 days after injury
|
Peak levels of ubiquitin C-terminal hydrolase L1 (UCH-L1)
Time Frame: First 5 days after injury
|
This hypothesis will be tested via linear regression model, with peak UCH-L1level as the response variable and hypoxia exposure as the predictor of interest.
Hypoxia exposure will be defined as the depth and duration of PbtO2 < 20 mmHg during the first 48 hours of injury, quantified using AUC methodology.
|
First 5 days after injury
|
Peak levels of neurofilament light chain (NfL)
Time Frame: First 5 days after injury
|
This hypothesis will be tested via linear regression model, with peak NfL level as the response variable and hypoxia exposure as the predictor of interest.
Hypoxia exposure will be defined as the depth and duration of PbtO2 < 20 mmHg during the first 48 hours of injury, quantified using AUC methodology.
|
First 5 days after injury
|
Peak levels of Tau
Time Frame: First 5 days after injury
|
This hypothesis will be tested via linear regression model, with peak Tau level as the response variable and hypoxia exposure as the predictor of interest.
Hypoxia exposure will be defined as the depth and duration of PbtO2 < 20 mmHg during the first 48 hours of injury, quantified using AUC methodology.
|
First 5 days after injury
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00042151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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