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

doi:10.1007/978-3-030-59436-7_29

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

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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 language	English
Pages (from-to)	143-147
Number of pages	5
Journal	Acta Neurochirurgica, Supplement
Volume	131
DOIs	https://doi.org/10.1007/978-3-030-59436-7_29
Publication status	Published - 2021

Keywords

Brain Injuries, Traumatic/therapy
Cerebrovascular Circulation
Feasibility Studies
Humans
Intracranial Pressure
Retrospective Studies

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10.1007/978-3-030-59436-7_29

Cite this

Tas, J., Beqiri, E., van Kaam, C. R., Ercole, A., Bellen, G., Bruyninckx, D., Cabeleira, M., Czosnyka, M., Depreitere, B., Donnelly, J., Fedriga, M., Hutchinson, P. J., Menon, D., Meyfroidt, G., Liberti, A., Outtrim, J. G., Robba, C., Hoedemaekers, C. W. E., Smielewski, P., & Aries, M. J. (2021). 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. Acta Neurochirurgica, Supplement, 131, 143-147. https://doi.org/10.1007/978-3-030-59436-7_29

@article{2fd980b12924438f842876720d705559,

title = "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",

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.",

keywords = "Brain Injuries, Traumatic/therapy, Cerebrovascular Circulation, Feasibility Studies, Humans, Intracranial Pressure, Retrospective Studies",

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

note = "Funding Information: M.J. Aries has received a clinical grant from the European Society of Intensive Care Medicine to support the COGiTATE study. Publisher Copyright: {\textcopyright} 2021, Springer Nature Switzerland AG.",

year = "2021",

doi = "10.1007/978-3-030-59436-7_29",

language = "English",

volume = "131",

pages = "143--147",

journal = "Acta Neurochirurgica, Supplement",

issn = "0065-1419",

publisher = "Springer",

}

Tas, J, Beqiri, E, van Kaam, CR, Ercole, A, Bellen, G, Bruyninckx, D, Cabeleira, M, Czosnyka, M, Depreitere, B, Donnelly, J, Fedriga, M, Hutchinson, PJ, Menon, D, Meyfroidt, G, Liberti, A, Outtrim, JG, Robba, C, Hoedemaekers, CWE, Smielewski, P & Aries, MJ 2021, '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', Acta Neurochirurgica, Supplement, vol. 131, pp. 143-147. https://doi.org/10.1007/978-3-030-59436-7_29

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. / Tas, Jeanette; Beqiri, Erta; van Kaam, C R et al.
In: Acta Neurochirurgica, Supplement, Vol. 131, 2021, p. 143-147.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - An Update on the COGiTATE Phase II Study

T2 - Feasibility and Safety of Targeting an Optimal Cerebral Perfusion Pressure as a Patient-Tailored Therapy in Severe Traumatic Brain Injury

AU - Tas, Jeanette

AU - Beqiri, Erta

AU - van Kaam, C R

AU - Ercole, Ari

AU - Bellen, Gert

AU - Bruyninckx, D

AU - Cabeleira, Manuel

AU - Czosnyka, Marek

AU - Depreitere, Bart

AU - Donnelly, Joseph

AU - Fedriga, Marta

AU - Hutchinson, Peter J

AU - Menon, D

AU - Meyfroidt, Geert

AU - Liberti, Annalisa

AU - Outtrim, J G

AU - Robba, C

AU - Hoedemaekers, C W E

AU - Smielewski, Peter

AU - Aries, Marcel J

N1 - Funding Information: M.J. Aries has received a clinical grant from the European Society of Intensive Care Medicine to support the COGiTATE study. Publisher Copyright: © 2021, Springer Nature Switzerland AG.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Brain Injuries, Traumatic/therapy

KW - Cerebrovascular Circulation

KW - Feasibility Studies

KW - Humans

KW - Intracranial Pressure

KW - Retrospective Studies

U2 - 10.1007/978-3-030-59436-7_29

DO - 10.1007/978-3-030-59436-7_29

M3 - Article

C2 - 33839835

SN - 0065-1419

VL - 131

SP - 143

EP - 147

JO - Acta Neurochirurgica, Supplement

JF - Acta Neurochirurgica, Supplement

ER -