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The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)

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ClinicalTrials.gov Identifier: NCT04855396
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Frederick Korley, MD, PhD, University of Michigan

Brief Summary:

There are no therapeutic agents that have been shown to improve outcomes from severe traumatic brain injury (TBI). Critical barriers to progress in developing treatments for severe TBI are the lack of: 1) monitoring biomarkers for assessing individual patient response to treatment; 2) predictive biomarkers for identifying patients likely to benefit from a promising intervention. Currently, clinical examination remains the fundamental tool for monitoring severe TBI patients and for subject selection in clinical trials. However, these patients are typically intubated and sedated, limiting the utility of clinical examinations. Validated monitoring and predictive biomarkers will allow titration of the dose of promising therapeutics to individual subject response, as well as make clinical trials more efficient by enabling the enrollment of subjects likely to benefit. Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP) are promising biomarkers that may be useful as 1) monitoring biomarkers; 2) predictive biomarkers in severe TBI trials. Although the biological rationale supporting their use is strong, significant knowledge gaps remain. To address these gaps in knowledge, we propose an ancillary observational study leveraging an ongoing severe TBI clinical trial that is not funded to collect biospecimen. The Hyperbaric Oxygen in Brain Injury Treatment (HOBIT) trial, a phase II randomized control clinical trial that seeks to determine the dose of hyperbaric oxygen therapy (HBOT) that that has the highest likelihood of demonstrating efficacy in a phase III trial. The proposed study will: 1) validate the accuracy of candidate monitoring biomarkers for predicting clinical outcome; 2) determine the treatment effect of different doses of HBOT on candidate monitoring biomarkers; and 3) determine whether there is a biomarker defined subset of severe TBI that responds favorably to HBOT. This proposal will: 1) inform a go/no-go decision for a phase III trial of HBOT by providing adjunctive evidence of the effect of HBOT on key biological pathways through which HBOT is hypothesized to affect outcome; 2) provide evidence to support further study of the first monitoring biomarkers of severe TBI; 3) increase the likelihood of success of a phase III trial by identifying the sub-population of severe TBI likely to benefit from HBOT; 4) create a repository of TBI biospecimen which may be accessed by other investigators.

This study is related to NCT04565119


Condition or disease
Traumatic Brain Injury

Detailed Description:

The Investigators will obtain an initial set of biospecimens (serum, plasma, CSF, DNA) as soon as feasible after randomization to a HOBIT study arm, but no later than 24 hours from injury. Subsequent biospecimens will be obtained every 8 hours (+/- 1 hour) for the first 24 hours post-enrollment. This will allow the characterization of acute changes in biomarker levels. On study days 2, 3, 5, 7 and 14 biospecimens will be obtained once a day to allow characterization of sub-acute changes in biomarker levels. If feasible, samples should be collected at 8am (+/- 2 hours) to minimize the effects of circadian rhythm on biomarker levels. In addition, during the first 5 days of the study, one set of biospecimen will be collected 4 hours after HBO treatment to examine the acute effects of HBO treatment on biomarkers. This will not apply to those randomized to non-HBOT groups. During the 6-month visit, 1 tablespoon (15 ml) of blood will be collected. In addition, for subjects who have an external ventricular drain in place, 5 cc of CSF will be collected at each time point if feasible. Since subjects are unlikely to have an EVD after the first week post-injury, CSF samples will be collected only for as long as the EVD is in place.

BioHOBIT will utilize data collected in the HOBIT 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Biomarkers in the Hyperbaric Oxygen Brain Injury Treatment Trial (BioHOBIT)
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Severe Traumatic Brain Injury
Participants will be enrolled in the HOBIT trial



Primary Outcome Measures :
  1. Unfavorable Neurologic Outcome [ Time Frame: 6-months post injury ]
    Glasgow Outcome Scale Extended with a score of <5. Score ranges from 1 to 8, with 1 = death, 8 = Complete Recovery.


Biospecimen Retention:   Samples With DNA
Serum/plasma and CSF samples will be analysed for measurments of: Glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and high sensitivity c-reactive protein (hsCRP)


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators plan to enroll a maximum of 150 male and female subjects among multiple clinical sites.
Criteria

Inclusion Criteria:

  • Enrolled in HOBIT (this is an ancillary study to the HOBIT Trial)

Exclusion Criteria:

  • Profoundly anemic (subjects who are profoundly anemic require blood transfusion)
  • Blood samples cannot be obtained

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855396


Contacts
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Contact: Natalie Fisher 734-232-2012 brownnat@med.umich.edu
Contact: Frederick Korley, MD, PhD 734-647-0261 korley@med.umich.edu

Locations
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United States, California
UCSD Medical Center - Hillcrest Hospital Recruiting
San Diego, California, United States, 92103
Contact: Todd Costantini         
United States, Florida
St. Mary's Medical Center Not yet recruiting
West Palm Beach, Florida, United States, 33407
Contact: Robert Borrego         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Nick Mohr         
United States, Kentucky
University of Kentucky Hospital Recruiting
Lexington, Kentucky, United States, 40536
Contact: Kevin Hatton         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Kinjal Sethuraman         
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Anthony Lagina         
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Michelle Biros         
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Jeff Cooper         
United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Luke James         
United States, Ohio
OSU Wexner Medical Center Active, not recruiting
Columbus, Ohio, United States, 43210
Canada, Ontario
Hamilton General Hospital Active, not recruiting
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Frederick Korley, MD, PhD University of Michigan
Principal Investigator: William Barsan, MD University of Michigan
Principal Investigator: Gaylan Rockswold, MD, PhD Hennepin Healthcare
Principal Investigator: Byron Gajewski, PhD University of Kansas
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Responsible Party: Frederick Korley, MD, PhD, Associate Professor of Emergency Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT04855396    
Other Study ID Numbers: Pro00024234
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frederick Korley, MD, PhD, University of Michigan:
Monitoring Biomarkers
Predictive Biomarkers
Glial Fibrillary Acidic Protein
Neurofilament Light Chain
High Sensitivity C-Reactive Protein
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System