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

NCT ID: NCT04565119

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-20
• Study Completion Date: 2027-12-31

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.

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No intervention. This is an observational study.

Intervention Type: OTHER

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

Interventions

No intervention. This is an observational study.

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: NOT_YET_RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ramon Diaz-Arrastia, MD, PhD

Role: CONTACT

Ramon.Diaz-Arrastia@pennmedicine.upenn.edu

215-662-9732

Cynthia Diaczynsky

Role: CONTACT

cynthia.diaczynsky@pennmedicine.upenn.edu

Facility Contacts

Fred Korley, MD, PhD

Role: primary

korley@med.umich.edu

Ramon Diaz-Arrastia, MD, PhD

Role: primary

Ramon.Diaz-Arrastia@pennmedicine.upenn.edu

800-789-7366

References

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.

Reference Type: BACKGROUND

PMID: 29028696 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00042151

Identifier Type: -

Identifier Source: org_study_id