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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

BOOST3 Trial 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.

BOOST3 Trial 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.

BOOST3 Trial 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

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

BOOST3 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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,376,964 Total Patients Enrolled

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,340 Previous Clinical Trials

648,265 Total Patients Enrolled

University of WashingtonOTHER

1,741 Previous Clinical Trials

1,846,672 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities still available to take part in this clinical experiment?

"Affirmative. The clinicaltrial.gov database states that this medical experiment, inaugural in late August 2019, is currently enrolling patients. 1094 individuals must be recruited from 35 distinct sites to successfully complete the trial."

Answered by AI

How many test subjects are engaged in this experiment?

"As mandated by the inclusion criteria, 1094 willing participants are needed to complete this trial. Patients may sign up at Duke University Hospital in Durham or UPMC Presbyterian Hospital in Pittsburgh."

Answered by AI

In what locations is this clinical experiment being conducted?

"The trial is taking place in an array of 35 sites which includes, but not limited to, Durham, Pittsburgh and Houston. For convenience purposes when signing up for the study it is recommended that you locate your nearest clinic to reduce travel time."

Answered by AI

Who else is applying?

What state do they live in?

North Carolina

Connecticut

New Mexico

What site did they apply to?

Yale New Haven Hospital

University of New Mexico Hospital

University of North Carolina Medical Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I suffered a TBI and am still recovering. I would like to find treatments that could improve my cognitive function.

PatientReceived 2+ prior treatments

I had a severe closed injury many years back frontal lobe and left side of brain. Intercranial pressure on and off is very bad.

PatientReceived 1 prior treatment

I have tried to receive better help through the VA and I have waited 2 years to go through their TBI program. I’ve recently over the last 3 years have had more seizures, which have made me fall, so I’ve given myself multiple concussions. My TBI symptoms have increased, and I honestly will do anything to help improve my quality of health.I’m currently rated 80% VA disability for my TBI.

PatientReceived 2+ prior treatments