NCT05566431

Brief Summary

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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
428

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
6 countries

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Mar 2023Jan 2028

First Submitted

Initial submission to the registry

June 10, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 4, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

4.9 years

First QC Date

June 10, 2022

Last Update Submit

June 25, 2025

Conditions

Severe Traumatic Brain Injury

Keywords

sTBIICP monitoringrandomized controlled trialTBI managementLatin AmericapediatricPhase III

Outcome Measures

Primary Outcomes (1)

  • Pediatric Quality of Life Inventory (PedsQL)

    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.

    6 months after injury

Secondary Outcomes (5)

  • Pediatric Quality of Life Inventory (PedsQL)

    3 months after injury

  • Glasgow Outcome Scale - Extended (GOS-E) Pediatric

    3 and 6 months after injury

  • Mortality

    3 and 6 months

  • Brain-specific interventions

    1 month average

  • ICU length of stay

    1 month average

Study Arms (2)

ICP monitoring based Protocol

ACTIVE COMPARATOR

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

Other: ICP

No ICP Monitoring Protocol CREVICE

ACTIVE COMPARATOR

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

Other: CREVICE

Interventions

ICPOTHER

The intervention is a management protocol that includes ICP monitoring for children with severe traumatic brain injury

Also known as: Intracranial-pressure-monitoring-based management protocol
ICP monitoring based Protocol
CREVICEOTHER

The intervention is a management protocol that is based on imaging and clinical examinations without ICP monitoring for children with severe traumatic brain injury

Also known as: Imaging-and-clinical-examination-based management protocol
No ICP Monitoring Protocol CREVICE

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of Washington, Harborview Medical Center

Seattle, Washington, 98104, United States

NOT YET RECRUITING

Fundación Hospital de la Misericordia

Bogotá, Colombia

RECRUITING

Hospital Fundacion Amigos de la Salud

Montería, Colombia

RECRUITING

Hospital de Niños Benjamín Bloom

San Salvador, El Salvador

RECRUITING

Hospital Regional de Esquintla

Escuintla, Guatemala

RECRUITING

Hospital General San Juan de Dios

Guatemala City, Guatemala

RECRUITING

Hospital Regional de Occidente San Juan de Dios

Quetzaltenango, Guatemala

RECRUITING

Hospital Escuela

Tegucigalpa, Honduras

RECRUITING

Hospital de Emergencias Pediátricas

Lima, Peru

RECRUITING

Hospital Edgardo Rebagliati Martins

Lima, Peru

RECRUITING

Instituto Nacional de Salud del Niño - San Borja

Lima, Peru

RECRUITING

Related Publications (2)

  • Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow RH, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Research Algorithms. Neurosurgery. 2024 Jan 1;94(1):72-79. doi: 10.1227/neu.0000000000002760. Epub 2023 Nov 13.

    PMID: 37955439DERIVED

  • Chesnut R, Temkin N, Pridgeon J, Sulzbacher S, Lujan S, Videtta W, Moya-Barquin L, Chaddock K, Bonow R, Petroni G, Guadagnoli N, Hendrickson P, Ramirez Cortez G, Carreazo NY, Vargas Aymituma A, Anchante D, Caqui P, Ramirez A, Munaico Abanto M, Ortiz Chicchon M, Cenzano Ramos J, Mazate-Mazariegos A, Castro Darce MDC, Sierra Morales R, Brol Lopez P, Menendez W, Posadas Gutierrez S, Kevin V, Mazariegos A, de Leon E, Rodas Barrios RE, Rodriguez S, Flores S, Alvarado O, Guzman Flores LJ, Moisa Martinez M, Gonzalez P. Development of a Randomized Trial Comparing ICP-Monitor-Based Management of Severe Pediatric Traumatic Brain Injury to Management Based on Imaging and Clinical Examination Without ICP Monitoring-Study Protocol. Neurosurgery. 2024 Jan 1;94(1):65-71. doi: 10.1227/neu.0000000000002582. Epub 2023 Jul 6.

    PMID: 37409817DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Randall Chesnut, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Randall M Chesnut, MD

CONTACT

2067449322chesnutr@uw.edu

Kelley Chaddock, BA

CONTACT

2067449322chaddk@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will not go into the ICU when a study participant is being treated, unmasked study staff will not inform the outcome assessor which protocol was used for a participant. and outcome assessors will remind participant's parents to refrain for telling them which treatment protocol was used for the participant.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In a Phase III multicenter, parallel-group, randomized superiority trial in 428 children with sTBI from 7 Latin American pediatric trauma centers, the objective is to test the efficacy of the treatment protocol from the Guidelines based on ICP monitoring among children with sTBI in improving global outcome measured by Pediatric Quality of Life Inventory (PedsQL) 6 mos after injury compared to treatment based on a non-invasive imaging \& clinical examination (CREVICE) protocol specifically modified for a pediatric population.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Medicine

Study Record Dates

First Submitted

June 10, 2022

First Posted

October 4, 2022

Study Start

March 22, 2023

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

When the study is completed, access to study data may be provided through the UW Data Repository for future analyses about brain injury, its treatment, and outcomes or other scientifically appropriate questions. A de-identified dataset will be provided to successful candidates for the specified use.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be made available 1 year after the primary study results are published.
Access Criteria
Researchers will complete a data use agreement that includes the questions to be answered with the data.

Locations

CO(2)US(1)GU(3)PE(3)HO(1)EL(1)