Brain Oxygen Optimization in Severe Traumatic Brain Injury - Phase 3 (BOOST-3)

严重创伤性脑损伤中的脑氧优化 - 第 3 阶段 (BOOST-3)

基本信息

批准号：
9730632
负责人：
WILLIAM G BARSAN
金额：
$ 598.09万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9730632
关键词：
Admission activity Adopted Adverse event American Area Behavior assessment Brain Brain Hypoxia Brain Injuries Caring Cause of Death Clinical Clinical Research Clinical Trials Clinical Trials Network Cognitive Coma Conscious Control Groups Data Devices Emergency Care Enrollment Family Glasgow Coma Scale Glasgow Outcome Scale Head Hospitalization Hospitals Hour Hypoxia Informed Consent Injury Intensive Care Units Intervention Intracranial Hypertension Intracranial Pressure Left Life Measures Medical Monitor Morbidity - disease rate Neurologic Neurological outcome Outcome Outcome Measure Oxygen Partial Pressure Participant Patient Monitoring Patients Phase Post-Head Injury Coma Procedures Protocols documentation Randomized Randomized Clinical Trials Randomized Controlled Trials Recovery Safety Severities Societies Supportive care Technology Time Traumatic Brain Injury Treatment Protocols United States United States Food and Drug Administration base behavioral outcome brain tissue clinical center clinical efficacy clinical research site clinically relevant cognitive testing cost estimate design disability effective intervention experience functional outcomes improved innovation mortality nerve injury prevent primary outcome psychosocial safety and feasibility secondary outcome severe injury trend

Admission activity Adopted Adverse event American Area Behavior assessment Brain Brain Hypoxia Brain Injuries Caring Cause of Death Clinical Clinical Research Clinical Trials Clinical Trials Network Cognitive Coma Conscious Control Groups Data Devices Emergency Care Enrollment Family Glasgow Coma Scale Glasgow Outcome Scale Head Hospitalization Hospitals Hour Hypoxia Informed Consent Injury Intensive Care Units Intervention Intracranial Hypertension Intracranial Pressure Left Life Measures Medical Monitor Morbidity - disease rate Neurologic Neurological outcome Outcome Outcome Measure Oxygen Partial Pressure Participant Patient Monitoring Patients Phase Post-Head Injury Coma Procedures Protocols documentation Randomized Randomized Clinical Trials Randomized Controlled Trials Recovery Safety Severities Societies Supportive care Technology Time Traumatic Brain Injury Treatment Protocols United States United States Food and Drug Administration base behavioral outcome brain tissue clinical center clinical efficacy clinical research site clinically relevant cognitive testing cost estimate design disability effective intervention experience functional outcomes improved innovation mortality nerve injury prevent primary outcome psychosocial safety and feasibility secondary outcome severe injury trend

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项目摘要

Traumatic brain injury (TBI) is a major cause of death and disability. Of the 3.5 million Americans who sustain a TBI every year, approximately 27,000 experience prolonged traumatic coma, the most severe form of TBI. Less than 20% of these patients make a good recovery, and most are left with life-long disabilities. ICU management of severe TBI focuses on monitoring intracranial pressure (ICP), but data from recently conducted randomized clinical trials indicate that this approach is overly simplistic. Another approach is to monitor the partial pressure of oxygen in brain tissue (PbtO2) and apply interventions to prevent brain tissue hypoxia and improve neurologic outcome. Clinical studies demonstrate that brain tissue hypoxia is common, that there is a strong relationship between low PbtO2 and poor outcome, and that timely interventions can reverse brain tissue hypoxia. The first randomized controlled trial of PbtO2 monitoring in severe TBI, titled “Brain Oxygen Optimization in Severe TBI (BOOST) Phase 2,” enrolled 122 subjects and demonstrated that the mean hypoxia burden was reduced by 74% by the treatment protocol informed by PbtO2 monitoring (p < 0.0001), and there were no significant safety issues. There was a trend towards improved functional outcome, supporting the pre-determined non-futility hypothesis. We are proposing the BOOST-3 trial to determine if there is evidence of clinical efficacy of a treatment protocol based on PbtO2 monitoring compared to treatment based on ICP monitoring alone. BOOST-3 will enroll patients with severe TBI requiring placement of ICP monitors within 6 hours of presentation to a participating hospital. Patients will be randomized to a treatment protocol based on ICP monitoring alone or the combination of ICP and PbtO2 monitoring. The Glasgow Outcome Scale-Extended (GOS-E) measured at 6 months post injury will be the primary outcome. Other secondary outcomes include functional, cognitive and behavioral assessments at 6 months, safety, survival to discharge, shortened time to follow commands, and reduction of total brain hypoxia exposure.

创伤性脑损伤（TBI）是死亡和残疾的主要原因。在350万维持一个的美国人中每年TBI，大约27,000次经历了长时间的创伤性昏迷，这是最严重的TBI。这些患者中只有不到20％的康复良好，并且大多数患有终身残疾。 ICU 严重TBI的管理重点是监测颅内压（ICP），但从最近开始的数据进行了随机临床试验，表明这种方法过于简单。另一个方法是监测脑组织（PBTO2）中氧气的部分压力，并采用干预措施以防止脑组织缺氧并改善神经系统结局。临床研究表明，脑组织缺氧很常见，低PBTO2和不良结果之间存在牢固的关系，并且及时的干预措施可以反向脑组织缺氧。严重TBI中PBTO2监测的第一个随机对照试验，标题为 “在严重的TBI（Boost）第2阶段中优化脑氧优化”，招募了122名受试者，并证明了通过PBTO2监测告知的治疗方案，平均低氧伯恩减少了74％（P < 0.0001），没有重大的安全问题。有一种改善功能结果的趋势，支持预先确定的非实现假设。我们正在提出BOOST-3试验，以确定是否是否有证据表明，与治疗相比，基于PBTO2监测的治疗方案的临床效率仅基于ICP监控。 BOOST-3将招募患有严重TBI的患者需要放置ICP 向参与医院介绍后6小时内监视。患者将随机分配治疗基于ICP监视的协议或ICP和PBTO2监视的组合。格拉斯哥受伤后6个月测得的结果量表扩展（GOS-E）将是主要结果。其他次要结果包括6个月的功能，认知和行为评估，安全性，生存放电，缩短遵循命令的时间以及减少总脑缺氧暴露。