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严重 TBI 中的脑氧优化，第 3 阶段 (BOOST3)

2026年11月6日 更新者：William Barsan、University of Michigan

严重 TBI 中的脑氧优化 (BOOST3)：一项比较有效性研究，用于测试基于监测脑组织氧分压的规定治疗方案的功效。

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU). The study will determine the safety and efficacy of a strategy guided by treatment goals based on both intracranial pressure (ICP) and brain tissue oxygen (PbtO2) as compared to a strategy guided by treatment goals based on ICP monitoring alone. Both of these alternative strategies are used in standard care. It is unknown if one is more effective than the other. In both strategies the monitoring and goals help doctors adjust treatments including the kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. The results of this study will help doctors discover if one of these methods is more safe and effective.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
主动，不招人

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

BOOST3 is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with traumatic brain injury (TBI) in the intensive care unit (ICU).

When a person has a TBI, their injured brain can swell over a period of hours or days. If the brain swells too much, the pressure in the skull increases and becomes dangerous, causing further injury to the brain. To try to prevent this, doctors usually insert a device, an ICP monitor, into the brain through a hole in the skull of people with severe TBI. An ICP monitor measures the pressure inside the skull. Most doctors agree that it is important to measure and prevent high ICP. Patients with injured brains also suffer additional injury to the brain if the amount of oxygen in the brain gets too low. Some doctors also insert a second device, a PbtO2 monitor, in the brain through the same or a second hole in the skull to measure brain tissue oxygen. A PbtO2 monitor measures how much oxygen is in a small area of the brain near the tip of the monitor. Other doctors think this is unnecessary and unhelpful. Both monitoring devices are approved by the US Food and Drug Administration (FDA) and Health Canada for patients with TBI. Both are commonly used. The ICP and PbtO2 goals guided by these monitors are used to help doctors adjust their treatment choices. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. Each of these treatment decisions is intended to improve outcomes. However, each treatment decision also involves potential risks. Different treatment decisions may result in different risks. This study will also help doctors better understand these risks. This study is funded by the National Institutes of Health because it answers questions important to the care of patients with TBI.

This study is a two-arm, single-blind, randomized, controlled, phase III, multi-center trial of ICU monitoring and treatment strategies for patients with severe TBI. It will compare the efficacy of ICU care guided by PbtO2 and ICP monitoring versus monitoring of ICP alone in the first 5 days after injury. Only subjects who have severe TBI and require invasive monitoring, according to Brain Trauma Foundation (BTF) and American College of Surgeons-Trauma Quality Improvement (ACS TQIP) guidelines, will be enrolled. All participants in this study will have both ICP monitors and PbtO2 monitors. Half of the participants will be randomized to an arm that includes treatment informed by PbtO2 and ICP, and half will be randomized to an arm that treats only ICP.

The PbtO2 values of those in the ICP only arm will be masked, so that the treating physicians will not be guided by PbtO2 information. Participants in the PbtO2 and ICP arm will have PbtO2 monitored and low measurements treated. Treatments to address physiological goals in both arms will follow a clinical standardization plan. Participants will be followed for 6 months and occurrence of serious adverse events or death will be recorded. Participants will have a follow-up interview to assess their level of recovery approximately 6 months post injury.

To reduce the likelihood of imbalance of important prognostic factors between groups, a covariate-adjusted randomization scheme will be used in this study. Adjustment variables are clinical site and probability of a poor outcome as defined by the IMPACT core model.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
1094

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 加拿大
      • Montreal、加拿大、H4J 1C5
        • CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
    • Alberta
      • Calgary、Alberta、加拿大、T2N 2T9
        • University of Calgary - Foothills Medical Centre
    • Ontario
      • Toronto、Ontario、加拿大、M5B 1W8
        • St. Michaels Hospital
  • 美国
    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center
      • Los Angeles、California、美国、90095-7436
        • Ronald Reagan UCLA Medical Center
      • Palo Alto、California、美国、94305
        • Stanford University Medical Center
      • Sacramento、California、美国、95817
        • UC Davis Medical Center
      • San Francisco、California、美国、94143
        • San Francisco General Hospital
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale New Haven Hospital
    • Florida
      • Gainesville、Florida、美国、32608
        • UF Health Shands Hospital
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Grady Memorial Hospital
    • Hawaii
      • Honolulu、Hawaii、美国、96813
        • The Queen's Medical Center
    • Illinois
      • Chicago、Illinois、美国、60637
        • University of Chicago Medical Center
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • St. Vincent Hospital
    • Maine
      • Portland、Maine、美国、04102
        • Maine Medical Center
    • Maryland
      • Baltimore、Maryland、美国、21287
        • Johns Hopkins Hospital
      • Baltimore、Maryland、美国、21201
        • University of Maryland Medical Center
    • Massachusetts
      • Boston、Massachusetts、美国、02215
        • Beth Israel Deaconess Medical Center
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital
      • Boston、Massachusetts、美国、02128
        • Massachusetts General Hospital
      • Worcester、Massachusetts、美国、01655
        • UMASS Memorial Medical Center
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan
      • Detroit、Michigan、美国、48201
        • Detroit Receiving Hospital
      • Detroit、Michigan、美国、48201
        • Henry Ford Hospital
    • Minnesota
      • Saint Paul、Minnesota、美国、55101
        • Regions Hospital
    • New Jersey
      • Camden、New Jersey、美国、08103
        • Cooper University Hospital
    • New Mexico
      • Albuquerque、New Mexico、美国、87131
        • University of New Mexico Hospital
    • New York
      • Flushing、New York、美国、11355
        • NewYork-Presbyterian Queens Hospital
      • Manhasset、New York、美国、11030
        • North Shore University Hospital
      • New York、New York、美国、10032
        • NYP Columbia University Medical Center
      • Rochester、New York、美国、14642
        • Strong Memorial Hospital
      • Syracuse、New York、美国、13210
        • SUNY Upstate Medical University
      • The Bronx、New York、美国、10461
        • Jacobi Medical Center
    • North Carolina
      • Chapel Hill、North Carolina、美国、27514
        • University of North Carolina Medical Center
      • Durham、North Carolina、美国、27710
        • Duke University Hospital
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • University of Cincinnati Medical Center
      • Columbus、Ohio、美国、43214
        • Riverside Methodist Hospital
      • Columbus、Ohio、美国、43210
        • OSU Wexner Medical Center
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health & Science University Hospital
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19107
        • Thomas Jefferson University Hospital
      • Philadelphia、Pennsylvania、美国、19104
        • Penn Presbyterian Medical Center
      • Pittsburgh、Pennsylvania、美国、15212
        • UPMC Presbyterian Hospital
    • Texas
      • Dallas、Texas、美国、75235
        • Parkland Hospital
      • Houston、Texas、美国、77030
        • Ben Taub General Hospital
      • San Antonio、Texas、美国、78229
        • University of Texas Health Science Center San Antonio
    • Utah
      • Salt Lake City、Utah、美国、84132
        • University of Utah Healthcare
    • Virginia
      • Richmond、Virginia、美国、23298
        • VCU Medical Center
    • Washington
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • WVU Healthcare Ruby Memorial Hospital
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Froedtert Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

14年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Non-penetrating traumatic brain injury
  • Glasgow Coma Scale (GCS) 3-8 measured off paralytics
  • Glasgow Coma Scale motor score < 6 if endotracheally intubated
  • Evidence of intracranial trauma on CT scan
  • Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
  • Able to place intracranial probes and randomize within 12 hours from injury
  • Age greater than or equal to 14 years

Exclusion Criteria:

  • Non-survivable injury
  • Bilaterally absent pupillary response in the absence of paralytic medication
  • Contraindication to the placement of intracranial probes
  • Treatment of brain tissue oxygen values prior to randomization
  • Planned use of devices which may unblind treating physicians to brain tissue hypoxia
  • Systemic sepsis at screening
  • Refractory hypotension
  • Refractory systemic hypoxia
  • PaO2/FiO2 ratio < 150
  • Known pre-existing neurologic disease with confounding residual neurological deficits
  • Known inability to perform activities of daily living (ADL) without assistance prior to injury
  • Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments
  • Pregnancy
  • Prisoner
  • On EFIC Opt-Out list as indicated by a bracelet or medical alert

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
有源比较器：ICP only

ICP guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP) caused by a swollen brain. This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.
其他：ICP guided management strategy

In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull, but PbtO2 is not used to guide care. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada, and are routinely used in patients with severe TBI. Doctors adjust their treatment choices to try to achieve this ICP goal. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.
有源比较器：ICP + PbtO2

ICP + PbtO2 guided management strategy: Care in the ICU of research participants randomized to this arm will be guided by a monitoring and treatment strategy in which doctors try to prevent high intracranial pressure (ICP), and also try to prevent low PbtO2 (brain tissue oxygen levels). This strategy is one of two alternative strategies that is currently used in standard care of patients with traumatic brain injury.
其他：ICP + PbtO2 guided management strategy

In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg and to avoid PbtO2 dropping below 20 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada for patients with severe TBI. The devices are used in standard care at hospitals participating in this research study. Doctors adjust their treatment choices to try to achieve these ICP and PbtO2 goals. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Glasgow Outcome Scale-Extended (GOS-E)
大体时间：6 months

The Glasgow Outcome Scale-Extended (GOS-E) is a global scale for functional outcome, in which higher scores indicate better outcomes. The GOS-E rates patient status into one of eight categories. A GOS-E score of 1 indicates death, 2 indicates a vegetative state, 3 or 4 indicates severe disability, 5 or 6 indicates moderate disability, and 7 or 8 indicates good recovery. The categories of severe disability, moderate disability and good recovery are subdivided into a lower and upper category. All injury related disabilities are assessed.
6 months

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Survival
大体时间：At discharge from hospital, an average of 19 days

Survival at discharge from hospital
At discharge from hospital, an average of 19 days
Total Brain Hypoxia Exposure
大体时间：Inclusive of up to 5 days of study intervention

The cumulative area on the time versus brain tissue oxygenation (PbtO2) curve in which PbtO2 is less than 20 mmHg.
Inclusive of up to 5 days of study intervention
Cognition: Rey Auditory Verbal Learning Test
大体时间：6 months

A measure of verbal learning and memory.
6 months
Cognition: Trail Making Test Part A+B
大体时间：6 months

A measure of attention, visual-motor tracking and executive functioning.
6 months
Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
大体时间：6 months

A measure of the presence and severity of post-concussion somatic, cognitive, and emotional symptoms.
6 months
Emotional Health: Brief Symptom Inventory 18
大体时间：6 months

A measure of psychological distress and psychiatric disorders.
6 months
Emotional Health: Satisfaction with Life Scale
大体时间：6 months

A measure of global cognitive judgments of one's life satisfaction.
6 months
Functional Status Exam
大体时间：6 months

Change in the activities of every day life as a function of a sudden event or illness
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
University of Michigan

合作者

合作者

为临床研究提供支持的赞助商以外的组织。这种支持可能包括与资金、设计、实施、数据分析或报告相关的活动。
Medical University of South Carolina
University of Pennsylvania
National Institute of Neurological Disorders and Stroke (NINDS)
University of Pittsburgh
University of Washington

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Lori Shutter, MD、University of Pittsburgh, Pittsburgh, PA 15260
  • 首席研究员：Ramon Diaz-Arrastia, MD, PhD、University of Pennsylvania, Philadelphia, PA 19104
  • 首席研究员：William Barsan, MD、University of Michigan, Ann Arbor, MI 48109
  • 首席研究员：Sharon Yeatts, PhD、Medical University of South Carolina, Charleston, SC 29425

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2019年8月28日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2027年11月1日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2027年11月1日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2018年11月16日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2018年11月22日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2018年11月27日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月12日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月6日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • BOOST3
  • U01NS099046 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 共享时间框架

1 year after publication on main outcome results paper

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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