A Prospective, Non-Randomized, Sequentially Enrolled, Multi-Center, Phase II Study to Evaluate the SENSE Device's Ability to Detect and Monitor Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Compare ICH in TBI patients to non-ICH control subjects
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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who meet all of the following inclusion criteria will be considered candidates for study enrollment:
- •Male or female subjects age 22 to 50
- •Patients with TBI who have a diagnostic head CT scan within 24 hours of the injury.
- •For patients with TBI without intracranial hemorrhage, Glasgow Coma Scale score at enrollment of ≤
- •For patients with TBI, intended clinical monitoring in the hospital setting for at least 6 hours from study enrollment.
- •Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian.
- •Willingness and ability to comply with schedule for study procedures.
- •Control subjects with normal brain health.
排除标准
- •All subjects meeting any of the following criteria will be excluded from this study:
- •Female patients who are pregnant or lactating.
- •Known history of seizure or clinical seizure prior to initiating SENSE monitoring.
- •Open skull fracture.
- •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 after the diagnostic (pre-enrollment) CT.
- •Planned withdrawal of care within 24 hours of enrollment.
- •Planned intracranial surgery within 24 hours of enrollment.
- •Current participation in a medical or surgical interventional clinical trial.
- •Planned or current use of continuous EEG monitoring.
- •Control subjects with normal brain health will have no known history of seizure, stroke, brain tumor, TBI
结局指标
主要结局
Compare ICH in TBI patients to non-ICH control subjects
时间窗: up to 12 months
1. Distinguish TBI subjects with intracranial hemorrhage from those without intracranial hemorrhage and from non-TBI controls.
Measure growth of intracranial hemorrhage
时间窗: up to 12 months
2. Detect new or enlarging intracranial hemorrhage of ≥ 6 ml among TBI subjects, as defined by CT scan.
次要结局
未报告次要终点