A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 6
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The study population will consist of 3 mutually-exclusive sets of patients and subjects:
- TBI patients with intracranial bleeding
- TBI patients without intracranial bleeding
- Control subjects with normal brain health.
Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating clinician and within 24 hours of injury.
详细描述
This study is a phase II, prospective, non-randomized, multi-center, within patient and between-group comparison of the SENSE Device and the standard diagnostic test, head CT scan, in patients with a diagnosis of TBI with or without intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, and/or traumatic contusions/intraparenchymal hemorrhage) and subjects with normal brain health for the detection of intracranial hemorrhages.
The following pair-wise comparisons will be performed to address the following research questions:
Is there a difference in the agreement between the head CT scan and the SENSE Device for detecting intracranial bleeding in patients with TBI? Patients with TBI with intracranial bleeding vs. Patients with TBI without intracranial bleeding (Objective no. 1)
Is there a difference in the false positive rate for the presence of bleeding between patients with TBI without intracranial bleeding and control subjects with normal brain health? Patients with TBI without intracranial bleeding vs. control subjects (Objective no. 1)
This study is a phase II, prospective, non-randomized, multi-center, within patient and between-group comparison of the SENSE Device and the standard diagnostic test, head CT scan, in patients with a diagnosis of TBI with or without intracranial bleeding (defined as epidural hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, and/or traumatic contusions/intraparenchymal hemorrhage) and subjects with normal brain health for the detection of intracranial hemorrhages.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male or female adults age 22 and older
- •Patients with TBI who have a head CT scan obtained in the mobile stroke unit, emergency department, or hospital, ordered by a treating clinician OR control subjects with normal brain health.
- •For patients with traumatic intracranial hemorrhage, blood is visible on ≥ 3 consecutive axial CT slices.
- •Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legally authorized representative.
- •Willingness and ability to comply with schedule for study procedures.
排除标准
- •• Female patients who are pregnant or lactating.
- •SENSE Device is unable to be placed within 6 hours of a standard of care head CT and within 24 hours of injury.
- •Open skull fracture (closed skull fracture is not an exclusion).
- •Metallic intracranial clip, coil, or device (such as metallic ICP monitor).
- •Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE Device monitoring or study participation or may confound the outcome of the study.
- •Planned placement of an intraventricular catheter prior to study enrollment.
- •Planned intracranial surgery prior to study enrollment.
- •Current participation in a medical or surgical interventional clinical trial.
- •Use of continuous EEG monitoring at the time of enrollment.
- •Clinical uncertainty about the presence or absence of hemorrhage on the enrolling head CT.
- •Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI requiring emergency room evaluation, concussion within the previous 6 months, hydrocephalus, intracranial vascular malformation, other structural brain disease, or intracranial surgery. Benign headache disorders (e.g. migraine headache, tension headache), and mild concussion > 6 months prior to enrollment are not exclusions.
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 12 months
The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.
次要结局
未报告次要终点