Traumatic Brain Injury
Conditions
Brief summary
The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).
Interventions
PROCEDUREBlood sample collection
Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.
Sponsors
Hoffmann-La Roche
Roche Diagnostics GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration/deceleration) * Acute brain CT completed for standard of care Further Inclusion Criteria (specific for CLIN12.2): * Admitted to the hospital with radiographic evidence of acute TBI * Admitted to the intensive care unit at risk for decline related to TBI
Exclusion criteria
* Prior neurosurgical intervention within the last 6 months * Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments * Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments * Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder) * History of melanoma * Primary diagnosis of ischemic or hemorrhagic stroke * Any spinal Cord Injury (American Spinal Injury Association \[ASIA\] score of A-D) * Received chemotherapy or radiation currently or within the last year * Patients on psychiatric hold (e.g., 5150, 5250) * Current incarceration or in custody * Known inability to undergo an MRI * Currently receiving any interventional treatments as a part of an investigational study/trial (drug, device, behavioral, treatment) at the time of enrollment and/or during the course of this study * Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts) * Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and/or in their future permanence in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants According to Traumatic Brain Injury (TBI) Diagnosis (Positive or Negative), Assessed by an Adjudication Panel Based on Structural Imaging (CT and MRI) and Clinical Summaries | Up to 2 weeks post-injury |
| Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints | Days 14, 28, and 90 |
| Percentage of Participants According to Neuroworsening Result (Positive or Negative), Assessed by an Adjudication Panel Based on Clinical and Radiological Findings | Up to 2 weeks post-injury |
| Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care | Up to 2 weeks post-injury |
| CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores | Days 14, 28, and 90 |
| CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores | Days 14, 28, and 90 |
| CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI | Up to 2 weeks post-injury |
| CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI | Up to 2 weeks post-injury |
Secondary
| Measure | Time frame |
|---|---|
| CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results | From Day 1 to 2 weeks post-injury |
| CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores | Days 14, 28, and 90 |
| CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores | Days 14, 28, and 90 |
| CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI | Up to 2 weeks post-injury |
| CLIN12.2: Specificity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI | Up to 2 weeks post-injury |
Countries
United States
Contacts
CONTACTMarian Martinez
STUDY_DIRECTORClinical Trials
Roche Diagnostics GmbH
Outcome results
None listed