An Update on the COGiTATE Phase II Study: Feasibility and Safety of Targeting an Optimal Cerebral Perfusion Pressure as a Patient-Tailored Therapy in Severe Traumatic Brain Injury

Jeanette Tas, Erta Beqiri, C. R. van Kaam, Ari Ercole, Gert Bellen, D. Bruyninckx, Manuel Cabeleira, Marek Czosnyka, Bart Depreitere, Joseph Donnelly, Marta Fedriga, Peter J. Hutchinson, D. Menon, Geert Meyfroidt, Annalisa Liberti, J. G. Outtrim, C. Robba, C. W.E. Hoedemaekers, Peter Smielewski, Marcel J. Aries

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Introduction: Monitoring of cerebral autoregulation (CA) in patients with a traumatic brain injury (TBI) can provide an individual ‘optimal’ cerebral perfusion pressure (CPP) target (CPPopt) at which CA is best preserved. This potentially offers an individualized precision medicine approach. Retrospective data suggest that deviation of CPP from CPPopt is associated with poor outcomes. We are prospectively assessing the feasibility and safety of this approach in the COGiTATE [CPPopt Guided Therapy: Assessment of Target Effectiveness] study. Its primary objective is to demonstrate the feasibility of individualizing CPP at CPPopt in TBI patients. The secondary objectives are to investigate the safety and physiological effects of this strategy. Methods: The COGiTATE study has included patients in four European hospitals in Cambridge, Leuven, Nijmegen, and Maastricht (coordinating centre). Patients with severe TBI requiring intracranial pressure (ICP)–directed therapy are allocated into one of two groups. In the intervention group, CPPopt is calculated using a published (modified) algorithm. In the control group, the CPP target recommended in the Brain Trauma Foundation guidelines (CPP 60–70 mmHg) is used. Results: Patient recruitment started in February 2018 and will continue until 60 patients have been studied. Fifty-one patients (85% of the intended total) have been recruited in October 2019. The first results are expected early 2021. Conclusion: This prospective evaluation of the feasibility, safety and physiological implications of autoregulation-guided CPP management is providing evidence that will be useful in the design of a future phase III study in severe TBI patients.

Original languageEnglish
Title of host publicationActa Neurochirurgica, Supplementum
PublisherSpringer Science and Business Media Deutschland GmbH
Pages143-147
Number of pages5
DOIs
Publication statusPublished - 2021

Publication series

NameActa Neurochirurgica, Supplementum
Volume131
ISSN (Print)0065-1419
ISSN (Electronic)2197-8395

Keywords

  • Cerebral autoregulation
  • COGiTATE
  • CPPopt
  • Optimal cerebral perfusion pressure
  • PRx

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology

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