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Protocol for a Randomized Trial Comparing Intracranial Pressure Monitor?Based Management of Severe Pediatric Traumatic Brain Injury with Management Based on Imaging and Clinical Ex...

Publicado por
Chesnut, Randall, Temkin, Nancy, Pridgeon, James, Sulzbacher, Stephen, Lujan, Silvia, Videtta, Walter, Moya-Barquín, Luis, Chaddock, Kelley, Bonow, Robert, Petroni, Gustavo, Guadagnoli, Nahuel, Hendrickson, Peter, Ramírez Cortez, Grimaldo, Carreazo, Nilton Yhuri, Vargas Aymituma, Alcides, Anchante, Daniel, Caqui, Patrick, Ramírez, Alberto, Munaico Abanto, Manuel, Ortiz Chicchon, Manuel, Cenzano Ramos, José, Mazate-Mazariegos, Analy, Castro Darce, María Del Carmen, Sierra Morales, Roberto, Brol Lopez, Pedro, Menendez, Willy, Posadas Gutierrez, Sofía, Kevin, Vicente, Mazariegos, Andrea, De Leon, Elie, Rodas Barrios, Rodolfo Enrique, Rodríguez, Sandra, Flores, Sandra, Alvarado, Ovidio, Guzman Flores, Luis José, Moisa Martinez, Melvin, Gonzalez, Pablo

Publicado 2023

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BACKGROUND AND OBJECTIVES: Traumatic brain injury (TBI) is a major global public health problem. It is a leading cause of death and disability in children and adolescents worldwide. Although increased intracranial pressure (ICP) is common and associated with death and poor outcome after pediatric TBI, the efficacy of current ICP-based management remains controversial. We intend to provide Class I evidence testing the efficacy of a protocol based on current ICP monitor-based management vs care based on imaging and clinical examination without ICP monitoring in pediatric severe TBI. METHODS: A phase III, multicenter, parallel-group, randomized superiority trial performed in intensive care units in Central and South America to determine the impact on 6-month outcome of children aged 1-12 years with severe TBI (age-Appropriate Glasgow Coma Scale score ?8) randomized to ICP-based or non-ICP-b...