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

Официальное название

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)

Обзор

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).

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (8)

• CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with TBI Diagnosis [Срок оценки: From Day 1 to 2 weeks post-injury]
• CLIN12.1: Specificity of Second Panel of Biomarkers Compared with TBI Diagnosis [Срок оценки: From Day 1 to 2 weeks post-injury]
• CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with Neuroworsening Results [Срок оценки: From Day 1 to 2 weeks post-injury]
• CLIN12.1: Specificity of Second Panel of Biomarkers Compared with Neuroworsening Results [Срок оценки: From Day 1 to 2 weeks post-injury]
• CLIN12.1: Sensitivity of Second Panel of Biomarkers Compared with GOSE-TBI Scores [Срок оценки: Days 14, 28, and 90]
• CLIN12.1: Specificity of Second Panel of Biomarkers Compared with GOSE-TBI Scores [Срок оценки: Days 14, 28, and 90]
• CLIN12.2: Sensitivity of a Second Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI [Срок оценки: 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 [Срок оценки: Up to 2 weeks post-injury]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 13 центров

• 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
• … и ещё 5 центров

Идентификаторы

NCT: NCT07455136 · RD007282

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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