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Study of Management Protocols for Severe Traumatic Brain Injury in Children

This study is for children aged 1 to 12 years old who have experienced a severe traumatic brain injury (TBI), which is a serious head injury. Researchers want to see if guiding treatment with Intracranial Pressure (ICP) monitoring, which measures pressure inside the skull, leads to better outcomes compared to a treatment plan called CREVICE. The CREVICE plan uses imaging and clinical exams without ICP monitoring. The study will look at how well children are doing 6 months after their injury using a tool called the Pediatric Quality of Life Inventory (PedsQL). To join, children must have a non-penetrating TBI, be admitted to the hospital within 24 hours of injury, and have a specific score on the Glasgow Coma Scale (GCS), which measures consciousness.

Study design
This is an interventional study planning to enroll 428 participants. It compares two different management protocols for severe traumatic brain injury in children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their injury to assess their quality of life.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05566431

Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics

Recruiting
NAAges 1–12InterventionalTreatment
University of Washington
~428 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:ICPCREVICE

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pediatric Quality of Life Inventory (PedsQL)
Measured over 6 months after injury

Conditions

Severe Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

11 sites across 6 states
Guatemala3
Peru3
Colombia2
Washington1
El Salvador1
Honduras1

Study leadership

  • Randall Chesnut, MD · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Randall M Chesnut, MD
[email protected]
2067449322
Email the study team

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Eligibility criteria

Inclusion

Within 24 hours of injury (for patients with GCS ≤ 8 on admission) OR
Within 24 hours of deterioration (for patients deteriorating to GCS ≤ 8 within 48 hours of injury)

What this trial measures

  • Pediatric Quality of Life Inventory (PedsQL)6 months after injury

    PedsQL is a generic, health-related quality of life instrument developed to measure the core dimensions of physical, cognitive, mental, social health, and role (school) function. Minimum and maximum values: 0-100. Higher scores have better outcomes.