Prospective, Open Label, Multi-centre, Controlled Phase 2a Clinical Trial to Investigate the Safety and Diagnostic Performance of the Multifunctional Hybrid Device Combining a Micro-dialysis Probe With an Intra-cortical Depth Electrode (DIALYTRODE) for Short Time Continuous Multimodal Neuro-monitoring of NICU Patients With Severe Brain Injury and Suspected Status Epilepticus in Surface EEG
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Number of adverse device effects (ADE) and serious adverse device effects (SADE)
研究概览
简要总结
This clinical trial evaluates the safety and diagnostic performance of a newly developed combined catheter that will be implanted into the brain of patients with severe brain injury for short time (up to 28 days) monitoring of the electric activity and the metabolism of brain tissue at risk. Ten patients will be monitored with the new device and seven patients will be monitored by intracerebral probes according to standard treatment.
详细描述
Early detection of nonconvulsive status epilepticus (NCSE) in patients treated in neurological intensive care unit (NICU) is essential, as delayed treatment can aggravate their clinical situation and worsen the outcome. In this study in intensive care patients with severe brain injury due to malignant middle cerebral artery (MCA) infarction, subarachnoidal hemorrhage (SAH) or intracerebral hemorrhage (ICH) with suspected status epilepticus in the surface EEG the hybrid catheter Dialytrode will be implanted in the cortical brain tissue by neurosurgeons for short time continuous bedside multimodal neuro-monitoring. Dialytrode combines a microdialysis catheter and depth EEG probe. Ten subjects will be monitored by Dialytrode and an additional (intracranial pressure (ICP) probe. Subjects with an clinical indication of an external ventricular drain (EVD) or cerebral microdialysis alone serve as control. The monitoring period with the device is limited to the microdialysis phase with a maximum of 28 days. Subjects will be followed up for 7 days after end of intracerebral monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical condition requiring treatment in NICU
- •MCA OR Subarachnoidal haemorrhage (SAH) OR Intracerebral haemorrhage (ICH)
- •Given indication of EVD with or without multimodal monitoring by micro-dialysis OR Given indication of multimodal monitoring by micro-dialysis and continuous depth EEG-monitoring due to (a) suspected SE in surface EEG (e.g. rhythmic pattern) or (b) refractory status epilepticus (RSE) in surface EEG or (c) an unclear situation of not waking up even though sedation is reduced OR Suspected SE without acute brain injury
排除标准
- •(main criteria):
- •Subject receiving anticoagulants in therapeutic dose
- •Bleeding disorder
- •Known contraindications for EEG depth electrodes or microdialysis probes
- •Presence of an infectious lesion of skin (limited to the scalp)
- •Presence of general contraindications for any surgical intervention
- •Sepsis or acute severe bacterial infection
- •Fragile bones of the skull
- •Severe organ failure or medical conditions displaying a contraindication for participating
- •Pregnant or nursing woman
研究组 & 干预措施
Dialytrode
Multimodal neuro-monitoring by dialytrode (investigational medical device)
干预措施: Dialytrode (Device)
Standard treatment
Either EVD and/or micro-dialysis according to standard treatment
干预措施: Standard treatment (Device)
结局指标
主要结局
Number of adverse device effects (ADE) and serious adverse device effects (SADE)
时间窗: Up to day 7±2 after removal of IMD or the single control devices respectively
Number of adverse device effects (ADE) and serious adverse device effects (SADE) from Baseline (day 1) to day 7+/-2 after removal of the investigational medical device (IMD) or the control devices respectively) in the intervention group compared to control
次要结局
未报告次要终点