Repository logo
 

Targeting Autoregulation-Guided Cerebral Perfusion Pressure after Traumatic Brain Injury (COGiTATE): A Feasibility Randomized Controlled Clinical Trial.

Accepted version
Peer-reviewed

Type

Article

Change log

Authors

Tas, Jeanette 
Beqiri, Erta 
van Kaam, Ruud C 
Czosnyka, Marek 
Donnelly, Joseph 

Abstract

Managing traumatic brain injury (TBI) patients with a cerebral perfusion pressure (CPP) near to the cerebral autoregulation (CA)-guided "optimal" CPP (CPPopt) value is associated with improved outcome and might be useful to individualize care, but has never been prospectively evaluated. This study evaluated the feasibility and safety of CA-guided CPP management in TBI patients requiring intracranial pressure monitoring and therapy (TBIicp patients). The CPPopt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) parallel two-arm feasibility trial took place in four tertiary centers. TBIicp patients were randomized to either the Brain Trauma Foundation (BTF) guideline CPP target range (control group) or to the individualized CA-guided CPP targets (intervention group). CPP targets were guided by six times daily software-based alerts for up to 5 days. The primary feasibility end-point was the percentage of time with CPP concordant (±5 mm Hg) with the set CPP targets. The main secondary safety end-point was an increase in therapeutic intensity level (TIL) between the control and intervention group. Twenty-eight patients were randomized to the control and 32 patients to the intervention group. CPP in the intervention group was in the target range for 46.5% (interquartile range, 41.2-58) of the monitored time, significantly higher than the feasibility target specified in the published protocol (36%; p < 0.001). There were no significant differences between groups for TIL or for other safety end-points. Conclusively, targeting an individual and dynamic CA-guided CPP is feasible and safe in TBIicp patients. This encourages a prospective trial powered for clinical outcomes.

Description

Keywords

cerebral autoregulation, cerebral perfusion, intensive care, optimal cerebral perfusion pressure, precision medicine, traumatic brain injury, Adult, Aged, Brain Injuries, Traumatic, Cerebrovascular Circulation, Endpoint Determination, Feasibility Studies, Female, Homeostasis, Humans, Male, Middle Aged, Neurophysiological Monitoring, Perfusion, Retrospective Studies, Software, Treatment Outcome

Journal Title

J Neurotrauma

Conference Name

Journal ISSN

0897-7151
1557-9042

Volume Title

38

Publisher

Mary Ann Liebert Inc

Rights

All rights reserved
Sponsorship
European Commission (602150)
National Institute for Health and Care Research (IS-BRC-1215-20014)