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Recruiting NCT07455136

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

— Observational Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample collection.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)

Overview

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

  • Procedure Blood sample collection
    Blood samples from each enrolled participant in CLIN12.1 and/or CLIN12.2 will be collected.

Primary outcome measures

  • 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 [Time frame: Up to 2 weeks post-injury]
  • Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints [Time frame: 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 [Time frame: Up to 2 weeks post-injury]
  • Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care [Time frame: Up to 2 weeks post-injury]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores [Time frame: Days 14, 28, and 90]
  • CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores [Time frame: Days 14, 28, and 90]
Secondary outcome measures (8)
  • CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results [Time frame: From Day 1 to 2 weeks post-injury]
  • CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores [Time frame: Days 14, 28, and 90]
  • CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores [Time frame: Days 14, 28, and 90]
  • CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI [Time frame: 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 [Time frame: Up to 2 weeks post-injury]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 13 centers
  • University Of California Davis, Neurological Surgery — Sacramento
  • University of California San Francisco — San Francisco
  • Goodman Campbell Brain and Spine/Ascension — Carmel
  • Northwell Health - Department Of Neurosurgery — Manhasset
  • Atrium Health - Carolina Medical Center — Charlotte
  • University of Cincinnati — Cincinnati
  • University of Pennsylvania Medical Center — Philadelphia
  • University of Pittsburgh Medical Center — Pittsburgh
  • … and 5 more centers

Identifiers

NCT: NCT07455136 · RD007282

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗