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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 万美国人中，每年，约有 27,000 人经历长时间的创伤性昏迷，这是 TBI 最严重的形式。这些患者中只有不到 20% 能得到良好康复，大多数人留下终生残疾。重症监护室严重 TBI 的治疗重点是监测颅内压 (ICP)，但最近的数据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 (PbtO2) 并采取干预措施来预防脑组织缺氧并改善神经系统结果。临床研究表明脑组织缺氧是常见的，低 PbtO2 与不良结果之间存在密切关系，及时干预可以逆转脑组织缺氧。第一个针对严重 TBI 监测 PbtO2 的随机对照试验，题为 “严重 TBI 中的脑氧优化 (BOOST) 第 2 阶段”招募了 122 名受试者，并证明通过 PbtO2 监测告知的治疗方案，平均缺氧负担减少了 74%（p < 0.0001），并且没有重大安全问题。有改善功能结果的趋势，支持预先确定的非无效假设。我们提议进行 BOOST-3 试验以确定是否有证据表明基于 PbtO2 监测的治疗方案与治疗相比具有临床疗效仅基于 ICP 监测。 BOOST-3 将招募需要放置 ICP 的严重 TBI 患者在到参与医院就诊后 6 小时内进行监测。患者将被随机分配接受治疗基于单独 ICP 监测或 ICP 和 PbtO2 监测组合的协议。格拉斯哥受伤后 6 个月测量的结果量表扩展 (GOS-E) 将是主要结果。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、生存期放电，缩短遵循命令的时间，并减少大脑总缺氧暴露。