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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 14
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cohort 2: Hospitalized Participants with TBI
干预措施: Blood sample collection (Procedure)
Cohort 1: Participants with Suspected TBI
干预措施: Blood sample collection (Procedure)
结局指标
主要结局
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
时间窗: Up to 2 weeks post-injury
Glasgow Outcome Scale-Extended (GOSE)-TBI Scores at Specified Timepoints
时间窗: 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
时间窗: Up to 2 weeks post-injury
Percentage of Hospitalized Participants with Secondary Events, Based on CT Scan Findings per the Standard of Care
时间窗: Up to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with TBI Diagnosis
时间窗: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with TBI Diagnosis
时间窗: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with Neuroworsening Results
时间窗: From Day 1 to 2 weeks post-injury
CLIN12.1: Specificity of First Panel of Biomarkers Compared with Neuroworsening Results
时间窗: From Day 1 to 2 weeks post-injury
CLIN12.1: Sensitivity of First Panel of Biomarkers Compared with GOSE-TBI Scores
时间窗: Days 14, 28, and 90
CLIN12.1: Specificity of First Panel of Biomarkers Compared with GOSE-TBI Scores
时间窗: Days 14, 28, and 90
CLIN12.2: Sensitivity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
时间窗: Up to 2 weeks post-injury
CLIN12.2: Specificity of a Biomarker Compared with the Development of Secondary Events in Hospitalized Participants with TBI
时间窗: Up to 2 weeks post-injury
次要结局
- 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)