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

Description

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

Conditions

Severe Traumatic Brain Injury

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Study Overview

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Study Details

Study overview

Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure monitoring produces better patient outcomes than care guided by a protocol without invasive monitoring. Study findings will inform clinical practice in treating pediatric severe TBI globally. Focused didactic and experience-based learning opportunities will increase the research capacity of pediatric intensivists in Latin America.

Pediatric Severe Traumatic Brain Injury in Latin America - A Randomized Trial Comparing Two Management Protocols

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

Condition
Severe Traumatic Brain Injury
Intervention / Treatment

-

Contacts and Locations

Seattle

University of Washington, Harborview Medical Center, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form by the parent(s) or guardian(s)
  • 2. Non-penetrating TBI
  • 3. Admission to study hospital within 24 hours of injury
  • 4. Total GCS score ≤ 8 on admission or within first 48 hours after injury (measured using pediatric GCS 1 for children \< 2 years old and standard GCS for older children)
  • 5. Age 1 through 12 years
  • 6. Able to randomize:
  • * 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)
  • 1. Motor GCS score of 6
  • 2. GCS of 3 with bilaterally fixed and dilated pupils
  • 3. Injury thought to be intentionally inflicted by a family member or caregiver.

Ages Eligible for Study

1 Year to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Randall Chesnut, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2026-12-31