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Advanced Monitoring Strategy for Severe Traumatic Brain Injury (BOOST3 Trial)

N/A
Recruiting
Led By Ramon Diaz-Arrastia, MD, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-penetrating traumatic brain injury
Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital
Must not have
Systemic sepsis at screening
Known inability to perform activities of daily living (ADL) without assistance prior to injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will help doctors determine whether a treatment strategy guided by both intracranial pressure and brain tissue oxygen is more effective than one guided by intracranial pressure alone.

Who is the study for?
This trial is for individuals aged 14 or older with severe traumatic brain injury (TBI), evidenced by a low Glasgow Coma Scale score and CT scan showing intracranial trauma. They must be able to have monitoring probes placed within specific time frames post-injury. Excluded are pregnant women, prisoners, those with certain medical conditions like systemic sepsis, or pre-existing neurological deficits that could affect the study.Check my eligibility
What is being tested?
BOOST3 compares two TBI treatment strategies in the ICU: one using goals based on both intracranial pressure (ICP) and brain tissue oxygen levels (PbtO2), versus another using ICP alone. The study aims to find out which method is safer and more effective for adjusting treatments such as medication doses, IV fluids, ventilator settings, etc.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include complications from probe placement like infection or bleeding, reactions to medications used during treatment adjustments based on monitoring results, and other risks associated with intensive care management of severe TBI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a brain injury without an object going through my skull.
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I can have brain probes placed within 6 hours of getting to the hospital.
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I can have probes placed in my brain within 12 hours of injury.
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I am 14 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have an infection in my blood.
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I needed help with daily activities before my injury.
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My pupils do not respond to light and I am not on muscle relaxants.
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My low blood pressure does not improve with treatment.
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I have a neurological condition that affects my movement or senses.
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My body doesn't respond to treatments for low oxygen levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Glasgow Outcome Scale-Extended (GOS-E)
Secondary outcome measures
Cognition: Rey Auditory Verbal Learning Test
Cognition: Trail Making Test Part A+B
Emotional Health: Brief Symptom Inventory 18
+5 more

Trial Design

2Treatment groups
Active Control
Group I: ICP onlyActive Control1 Intervention
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.
Group II: ICP + PbtO2Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,386,268 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
647,083 Total Patients Enrolled
University of WashingtonOTHER
1,762 Previous Clinical Trials
1,875,388 Total Patients Enrolled

Media Library

ICP guided management strategy Clinical Trial Eligibility Overview. Trial Name: NCT03754114 — N/A
Traumatic Brain Injury Research Study Groups: ICP only, ICP + PbtO2
Traumatic Brain Injury Clinical Trial 2023: ICP guided management strategy Highlights & Side Effects. Trial Name: NCT03754114 — N/A
ICP guided management strategy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03754114 — N/A
Traumatic Brain Injury Patient Testimony for trial: Trial Name: NCT03754114 — N/A
~435 spots leftby Nov 2027
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