Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial

NCT04565119 | Active Not Recruiting DMC

• 1 other identifier: 00042151
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.

Conditions

TBI (Traumatic Brain Injury)

Keywords

Biomarkers

Outcome Measures

Primary Outcomes (4)

• Peak levels of glial fibrillary acidic protein (GFAP)

  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)

  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)

  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

  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

Study Arms (1)

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.

Other: No intervention. This is an observational study.

Interventions

No intervention. This is an observational study. OTHER

There are no interventions being tested in the Bio-BOOST study.

Severe traumatic brain injury (TBI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to enroll a maximum of 300 male and female subjects among multiple clinical sites.

You may qualify if:

• 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

You may not qualify if:

• Profoundly anemic (subjects who are profoundly anemic require blood transfusion)
• Age less than 18 years

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of Michigan: collaborator
• University of Pittsburgh: collaborator
• Medical University of South Carolina: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial. Crit Care Med. 2017 Nov;45(11):1907-1914. doi: 10.1097/CCM.0000000000002619.

  PMID: 29028696 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum/plasma and CSF samples will be analysed for simultaneous measurement of glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L-1 (UCH-L1), tau, and neurofilament light chain (NF-L). These procedures will be carried out in Dr. Diaz-Arrastia's laboratory at the University of Pennsylvania, by a research scientist blinded to the clinical and physiologic data. There will be no difference in the distribution of samples by BOOST-3 treatment group. Other novel brain injury biomarkers will be assayed when they become available. Blood samples collected in the study may be used for both TBI research and the study of other medical conditions.

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: September 25, 2020
• Study Start: December 20, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available upon completion of the study in December of 2026.
• Access Criteria: FITBIR qualified investigators will be provided access.

Locations

US (2)