Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 5.
doi: 10.1227/neu.0000000000002777. Online ahead of print.

The Roles of Protocols and Protocolization in Improving Outcome From Severe Traumatic Brain Injury

Randall M Chesnut  1   2   3   4 , Nancy Temkin  1   5 , Walter Videtta  6 , Silvia Lujan  7   8 , Gustavo Petroni  3 , Jim Pridgeon  1 , Sureyya Dikmen  9 , Kelley Chaddock  1 , Terence Hendrix  10 , Jason Barber  1 , Joan Machamer  1 , Nahuel Guadagnoli  7   8 , Peter Hendrickson  1 , Victor Alanis  11 , Gustavo La Fuente  12 , Arturo Lavadenz  13 , Roberto Merida  14 , Freddy Sandi Lora  15 , Ricardo Romero  16 , Oscar Pinillos  17 , Zulma Urbina  18 , Jairo Figueroa  19 , Marcelo Ochoa  20 , Rafael Davila  21 , Jacobo Mora  22 , Luis Bustamante  23 , Carlos Perez  24 , Jorge Leiva  25 , Carlos Carricondo  26 , Ana Maria Mazzola  27 , Juan Guerra  28
Affiliations

The Roles of Protocols and Protocolization in Improving Outcome From Severe Traumatic Brain Injury

Randall M Chesnut et al. Neurosurgery. .

Abstract

Background and objectives: Our 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.

Methods: We 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.

Results: A 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).

Conclusion: Centers 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.

PubMed Disclaimer

References

    1. Chesnut RM, Temkin N, Carney N, et al. A trial of intracranial-pressure monitoring in traumatic brain injury. New Engl J Med. 2012;367(26):2471-2481.
    1. Chesnut RM, Temkin N, Dikmen S, et al. A method of managing severe traumatic brain injury in the absence of intracranial pressure monitoring: the imaging and clinical examination protocol. J Neurotrauma. 2018;35(1):54-63.
    1. Chesnut RM, Temkin N, Videtta W, et al. Testing the impact of protocolized care of patients with severe traumatic brain injury without intracranial pressure monitoring: the imaging and clinical examination protocol. Neurosurgery. 2023;92(3):472-480.
    1. Chesnut RM, Temkin N, Videtta W, et al. Consensus-based management protocol (CREVICE Protocol) for the treatment of severe traumatic brain injury based on imaging and clinical examination for use when intracranial pressure monitoring is not employed. J Neurotrauma. 2020;37(11):1291-1299.
    1. Marshall LF, Marshall SB, Klauber MR, et al. A new classification of head injury based on computerized tomography. J Neurosurg. 1991;75(Supplement):s14-s20.

LinkOut - more resources