• Randall M Chesnut, Nancy Temkin, Walter Videtta, Silvia Lujan, Gustavo Petroni, Jim Pridgeon, Sureyya Dikmen, Kelley Chaddock, Terence Hendrix, Jason Barber, Joan Machamer, Nahuel Guadagnoli, Peter Hendrickson, Victor Alanis, Gustavo La Fuente, Arturo Lavadenz, Roberto Merida, Freddy Sandi Lora, Ricardo Romero, Oscar Pinillos, Zulma Urbina, Jairo Figueroa, Marcelo Ochoa, Rafael Davila, Jacobo Mora, Luis Bustamante, Carlos Perez, Jorge Leiva, Carlos Carricondo, Ana Maria Mazzola, and Juan Guerra.
• Department of Neurological Surgery, University of Washington, Seattle, Washington, USA.
• Neurosurgery. 2023 Dec 5.

Background And ObjectivesOur Phase-I parallel-cohort study suggested that managing severe traumatic brain injury (sTBI) in the absence of intracranial pressure (ICP) monitoring using an ad hoc Imaging and Clinical Examination (ICE) treatment protocol was associated with superior outcome vs nonprotocolized management but could not differentiate the influence of protocolization from that of the specific protocol. Phase II investigates whether adopting the Consensus REVised Imaging and Clinical Examination (CREVICE) protocol improved outcome directly or indirectly via protocolization.MethodsWe performed a Phase-II sequential parallel-cohort study examining adoption of the CREVICE protocol from no protocol vs a previous protocol in patients with sTBI older than 13 years presenting ≤24 hours after injury. Primary outcome was prespecified 6-month recovery. The study was done mostly at public South American centers managing sTBI without ICP monitoring. Fourteen Phase-I nonprotocol centers and 5 Phase-I protocol centers adopted CREVICE. Data were analyzed using generalized estimating equation regression adjusting for demographic imbalances.ResultsA total of 501 patients (86% male, mean age 35.4 years) enrolled; 81% had 6 months of follow-up. Adopting CREVICE from no protocol was associated with significantly superior results for overall 6-month extended Glasgow Outcome Score (GOSE) (protocol effect = 0.53 [0.11, 0.95], P = .013), mortality (36% vs 21%, HR = 0.59 [0.46, 0.76], P < .001), and orientation (Galveston Orientation and Amnesia Test discharge protocol effect = 10.9 [6.0, 15.8], P < .001, 6-month protocol effect = 11.4 [4.1, 18.6], P < .005). Adopting CREVICE from ICE was associated with significant benefits to GOSE (protocol effect = 0.51 [0.04, 0.98], P = .033), 6-month mortality (25% vs 18%, HR = 0.55 [0.39, 0.77], P < .001), and orientation (Galveston Orientation and Amnesia Test 6-month protocol effect = 9.2 [3.6, 14.7], P = .004). Comparing both groups using CREVICE, those who had used ICE previously had significantly better GOSE (protocol effect = 1.15 [0.09, 2.20], P = .033).ConclusionCenters managing adult sTBI without ICP monitoring should strongly consider protocolization through adopting/adapting the CREVICE protocol. Protocolization is indirectly supported at sTBI centers regardless of resource availability.Copyright © Congress of Neurological Surgeons 2023. All rights reserved.

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