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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glasgow Outcome Scale-Extended (GOS-E)

Secondary study objectives

Cognition: Rey Auditory Verbal Learning Test

Cognition: Trail Making Test Part A+B

Emotional Health: Brief Symptom Inventory 18

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met