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重度の外傷性脳損傷における脳酸素の最適化、フェーズ 3 (BOOST3)

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

重度の外傷性脳損傷における脳酸素の最適化 (BOOST3): 脳組織酸素の分圧のモニタリングに基づいて処方された治療プロトコルの有効性をテストするための比較有効性研究。

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

1094

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

14年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
他の：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.
アクティブコンパレータ：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.
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Glasgow Outcome Scale-Extended (GOS-E)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Survival
時間枠：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
時間枠：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
時間枠：6 months

A measure of verbal learning and memory.
6 months
Cognition: Trail Making Test Part A+B
時間枠：6 months

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

A measure of psychological distress and psychiatric disorders.
6 months
Emotional Health: Satisfaction with Life Scale
時間枠：6 months

A measure of global cognitive judgments of one's life satisfaction.
6 months
Functional Status Exam
時間枠：6 months

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of Michigan

協力者

Medical University of South Carolina
University of Pennsylvania
National Institute of Neurological Disorders and Stroke (NINDS)
University of Pittsburgh
University of Washington

捜査官

  • 主任研究者：Lori Shutter, MD、University of Pittsburgh, Pittsburgh, PA 15260
  • 主任研究者：Ramon Diaz-Arrastia, MD, PhD、University of Pennsylvania, Philadelphia, PA 19104
  • 主任研究者：William Barsan, MD、University of Michigan, Ann Arbor, MI 48109
  • 主任研究者：Sharon Yeatts, PhD、Medical University of South Carolina, Charleston, SC 29425

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2019年8月28日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2018年11月16日

QC基準を満たした最初の提出物

2018年11月22日

最初の投稿 (実際)

2018年11月27日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月6日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • BOOST3
  • U01NS099046 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD 共有時間枠

1 year after publication on main outcome results paper

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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