Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics (BELLA TRIP-P)
Severe Traumatic Brain Injury
About this trial
This is an interventional treatment trial for Severe Traumatic Brain Injury focused on measuring sTBI, ICP monitoring, randomized controlled trial, TBI management, Latin America, pediatric, Phase III
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form by the parent(s) or guardian(s)
- Non-penetrating TBI
- Admission to study hospital within 24 hours of injury
- 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)
- Age 1 through 12 years
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)
Exclusion Criteria:
- Motor GCS score of 6
- GCS of 3 with bilaterally fixed and dilated pupils
- Injury thought to be intentionally inflicted by a family member or caregiver.
Sites / Locations
- University of Washington, Harborview Medical Center
- Hospital de Niños Benjamín BloomRecruiting
- Hospital Regional de EsquintlaRecruiting
- Hospital General San Juan de DiosRecruiting
- Hospital Regional de Occidente San Juan de DiosRecruiting
- Hospital EscuelaRecruiting
- Hospital de Emergencias PediátricasRecruiting
- Hospital Edgardo Rebagliati MartinsRecruiting
- Instituto Nacional de Salud del Niño - San BorjaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
ICP monitoring based Protocol
No ICP Monitoring Protocol CREVICE
Arm one will use a consensus-developed management protocol for paediatric severe traumatic brain injury based on recommendations from the Brain Trauma Foundation Guidelines, which uses invasive intracranial pressure monitoring
Arm two will use the Consensus-Revised Imaging and Clinical Examination (CREVICE) management protocol for paediatric severe traumatic brain injury based on imaging and clinical examination in the absence of invasive intracranial pressure monitoring