Ottimizzazione dell'ossigeno cerebrale nel trauma cranico grave, fase 3 (BOOST3)
Ottimizzazione dell'ossigeno cerebrale nel trauma cranico grave (BOOST3): uno studio di efficacia comparativa per testare l'efficacia di un protocollo di trattamento prescritto basato sul monitoraggio della pressione parziale dell'ossigeno nel tessuto cerebrale.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Montreal, Canada, H4J 1C5
- CIUSSS-NIM Hopital du Sacre - Coeur de Montreal
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- University of Calgary - Foothills Medical Centre
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Ontario
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Toronto, Ontario, Canada, M5B 1W8
- St. Michaels Hospital
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California
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Los Angeles, California, Stati Uniti, 90048
- Cedars-Sinai Medical Center
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Los Angeles, California, Stati Uniti, 90095-7436
- Ronald Reagan UCLA Medical Center
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Palo Alto, California, Stati Uniti, 94305
- Stanford University Medical Center
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Sacramento, California, Stati Uniti, 95817
- UC Davis Medical Center
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San Francisco, California, Stati Uniti, 94143
- San Francisco General Hospital
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- University of Colorado Hospital
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Yale New Haven Hospital
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Florida
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Gainesville, Florida, Stati Uniti, 32608
- UF Health Shands Hospital
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Georgia
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Atlanta, Georgia, Stati Uniti, 30303
- Grady Memorial Hospital
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96813
- The Queen's Medical Center
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- University of Chicago Medical Center
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Indiana
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Indianapolis, Indiana, Stati Uniti, 46260
- St. Vincent Hospital
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Maine
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Portland, Maine, Stati Uniti, 04102
- Maine Medical Center
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Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hospital
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland Medical Center
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Stati Uniti, 02128
- Massachusetts General Hospital
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Worcester, Massachusetts, Stati Uniti, 01655
- UMASS Memorial Medical Center
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Detroit, Michigan, Stati Uniti, 48201
- Detroit Receiving Hospital
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Detroit, Michigan, Stati Uniti, 48201
- Henry Ford Hospital
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Minnesota
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Saint Paul, Minnesota, Stati Uniti, 55101
- Regions Hospital
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New Jersey
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Camden, New Jersey, Stati Uniti, 08103
- Cooper University Hospital
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New Mexico
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Albuquerque, New Mexico, Stati Uniti, 87131
- University of New Mexico Hospital
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New York
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Flushing, New York, Stati Uniti, 11355
- NewYork-Presbyterian Queens Hospital
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Manhasset, New York, Stati Uniti, 11030
- North Shore University Hospital
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New York, New York, Stati Uniti, 10032
- NYP Columbia University Medical Center
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Rochester, New York, Stati Uniti, 14642
- Strong Memorial Hospital
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Syracuse, New York, Stati Uniti, 13210
- SUNY Upstate Medical University
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The Bronx, New York, Stati Uniti, 10461
- Jacobi Medical Center
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- University of North Carolina Medical Center
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Durham, North Carolina, Stati Uniti, 27710
- Duke University Hospital
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati Medical Center
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Columbus, Ohio, Stati Uniti, 43214
- Riverside Methodist Hospital
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Columbus, Ohio, Stati Uniti, 43210
- OSU Wexner Medical Center
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Oregon
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Portland, Oregon, Stati Uniti, 97239
- Oregon Health & Science University Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19107
- Thomas Jefferson University Hospital
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Penn Presbyterian Medical Center
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Pittsburgh, Pennsylvania, Stati Uniti, 15212
- UPMC Presbyterian Hospital
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Texas
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Dallas, Texas, Stati Uniti, 75235
- Parkland Hospital
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Houston, Texas, Stati Uniti, 77030
- Ben Taub General Hospital
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San Antonio, Texas, Stati Uniti, 78229
- University of Texas Health Science Center San Antonio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- University of Utah Healthcare
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Virginia
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Richmond, Virginia, Stati Uniti, 23298
- VCU Medical Center
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Washington
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Seattle, Washington, Stati Uniti, 98104
- Harborview Medical Center
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West Virginia
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Morgantown, West Virginia, Stati Uniti, 26506
- WVU Healthcare Ruby Memorial Hospital
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Wisconsin
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Milwaukee, Wisconsin, Stati Uniti, 53226
- Froedtert Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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. |
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. |
|
Comparatore attivo: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Glasgow Outcome Scale-Extended (GOS-E)
Lasso di tempo: 6 months
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Survival
Lasso di tempo: At discharge from hospital, an average of 19 days
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Survival at discharge from hospital |
At discharge from hospital, an average of 19 days
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Total Brain Hypoxia Exposure
Lasso di tempo: Inclusive of up to 5 days of study intervention
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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
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Cognition: Rey Auditory Verbal Learning Test
Lasso di tempo: 6 months
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A measure of verbal learning and memory. |
6 months
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Cognition: Trail Making Test Part A+B
Lasso di tempo: 6 months
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A measure of attention, visual-motor tracking and executive functioning. |
6 months
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Emotional Health: Rivermead Post-Concussion Symptom Questionnaire
Lasso di tempo: 6 months
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A measure of the presence and severity of post-concussion somatic, cognitive, and emotional symptoms. |
6 months
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Emotional Health: Brief Symptom Inventory 18
Lasso di tempo: 6 months
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A measure of psychological distress and psychiatric disorders. |
6 months
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Emotional Health: Satisfaction with Life Scale
Lasso di tempo: 6 months
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A measure of global cognitive judgments of one's life satisfaction. |
6 months
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Functional Status Exam
Lasso di tempo: 6 months
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Change in the activities of every day life as a function of a sudden event or illness |
6 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Lori Shutter, MD, University of Pittsburgh, Pittsburgh, PA 15260
- Investigatore principale: Ramon Diaz-Arrastia, MD, PhD, University of Pennsylvania, Philadelphia, PA 19104
- Investigatore principale: William Barsan, MD, University of Michigan, Ann Arbor, MI 48109
- Investigatore principale: Sharon Yeatts, PhD, Medical University of South Carolina, Charleston, SC 29425
Pubblicazioni e link utili
Pubblicazioni generali
- Okonkwo DO, Shutter LA, Moore C, Temkin NR, Puccio AM, Madden CJ, Andaluz N, Chesnut RM, Bullock MR, Grant GA, McGregor J, Weaver M, Jallo J, LeRoux PD, Moberg D, Barber J, Lazaridis C, Diaz-Arrastia RR. Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial. Crit Care Med. 2017 Nov;45(11):1907-1914. doi: 10.1097/CCM.0000000000002619.
- Bernard F, Barsan W, Diaz-Arrastia R, Merck LH, Yeatts S, Shutter LA. Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): a multicentre, randomised, blinded-endpoint, comparative effectiveness study of brain tissue oxygen and intracranial pressure monitoring versus intracranial pressure alone. BMJ Open. 2022 Mar 10;12(3):e060188. doi: 10.1136/bmjopen-2021-060188.
- Fiore M, Bogossian E, Creteur J, Oddo M, Taccone FS. Role of brain tissue oxygenation (PbtO2) in the management of subarachnoid haemorrhage: a scoping review protocol. BMJ Open. 2020 Sep 15;10(9):e035521. doi: 10.1136/bmjopen-2019-035521.
- Steinberg A, Case N, Yang Y, Fischhoff B, Callaway CW, Coppler PJ, Barsan WG, Diaz-Arrastia R, Geocadin R, Okonkwo DO, Shutter L, Silbergleit R, Meurer WJ, Yeatts SD, Elmer J. Clinicians' Approaches to Prognostication After Traumatic Brain Injury and Cardiac Arrest: A Multi-Hospital, Qualitative Study. Neurocrit Care. 2026 Aug;45(1):132-141. doi: 10.1007/s12028-026-02452-z. Epub 2026 Feb 12.
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Ferite e lesioni
- Segni e sintomi, respiratori
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Lesioni cerebrali
- Ipossia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Lesioni cerebrali, traumatiche
- Ipossia, cervello
Altri numeri di identificazione dello studio
- BOOST3
- U01NS099046 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Periodo di condivisione IPD
1 year after publication on main outcome results paper
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
Informazioni su farmaci e dispositivi, documenti di studio
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