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.
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.
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DOI：
10.1007/978-3-030-59436-7_29
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发表时间：
2021-01-01
期刊：
影响因子：
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通讯作者：
Aries, Marcel J
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文献类型：
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作者：
Tas, Jeanette;Beqiri, Erta;Aries, Marcel J
简介：监测创伤性脑损伤（TBI）患者的脑自动调节（CA）可以提供一个个体的“最佳”脑灌注压（CPP）目标（CPPopt），在该目标下CA得到最好的保护。这可能提供了一种个性化的精准医疗方法。回顾性数据表明，CPP偏离CPPopt与不良结局相关。我们正在COGiTATE [CPPopt引导治疗：靶点有效性评估]研究中前瞻性评估这种方法的可行性和安全性。其主要目的是证明TBI患者在CPPopt个体化CPP的可行性。次要目标是调查这种策略的安全性和生理学效应。方法：COGiTATE研究包括剑桥、鲁汶、奈梅亨和马斯特里赫特（协调中心）的四家欧洲医院的患者。将需要颅内压（ICP）定向治疗的重度TBI患者分为两组。在干预组中，CPPopt是使用已发表（修改）的算法计算的。在对照组中，使用脑创伤基金会指南中推荐的CPP目标（CPP 60 - 70 mmHg）。结果：患者招募于2018年2月开始，将持续到60例患者完成研究。2019年10月已招募51名患者（占预期总数的85%）。第一批结果预计将于2021年获得。结论：本前瞻性评估的可行性，安全性和生理意义的自我调节引导的CPP管理提供的证据，将是有用的设计，在未来的III期研究中的严重TBI患者。
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 COGiTATEstudy has included patients in four Europeanhospitals 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 (CPP60-70mmHg) 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 expectedearly 2021.CONCLUSION: This prospective evaluation of the feasibility, safety and physiological implications of autoregulation-guided CPPmanagement is providing evidence that will be useful in the design of a future phase III studyin severe TBI patients.