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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：
10265997
负责人：
WILLIAM G BARSAN
金额：
$ 624.73万
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 2025-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10265997
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

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350万维持生计的美国人中， TBI每年约有27，000人经历长期创伤性昏迷，这是TBI最严重的形式。这些患者中只有不到20%恢复良好，大多数人终身残疾。ICU 严重TBI的管理重点是监测颅内压（ICP），但最近的数据显示，进行的随机临床试验表明，这种方法过于简单化。另一种方法是监测脑组织中的氧分压（PbtO 2），并采取干预措施，防止脑组织缺氧和改善神经学结果。临床研究表明，脑组织缺氧是常见的，低PbtO 2和不良结局之间存在密切关系，及时干预可以逆转脑组织缺氧第一项关于严重TBI中PbtO 2监测的随机对照试验，标题为 “重度TBI脑氧优化（BOOST）2期”招募了122名受试者，并证明，通过PbtO 2监测告知的治疗方案，平均缺氧负荷减少了74%（p <0.05）。 0.0001），并且没有显著的安全性问题。有改善功能结局的趋势，支持预先确定的非无效假设。我们建议进行BOOST-3试验，以确定有证据表明，与治疗相比，基于PbtO 2监测的治疗方案具有临床疗效仅基于ICP监测。BOOST-3将入组需要放置ICP的重度TBI患者在向参与医院报告后6小时内进行监测。患者将随机接受治疗基于单独的ICP监测或ICP和PbtO 2监测的组合的方案。格拉斯哥酒店在损伤后6个月测量的结局量表扩展（GOS-E）将是主要结局。其他次要结局包括6个月时的功能、认知和行为评估，安全性、生存率，放电，缩短遵循命令的时间，并减少总脑缺氧暴露。