The Role of Neurofilament Light (NfL) in Management of Patients With Hydrocephalus: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of changes in valve settings
研究概览
简要总结
Neurofilament Light Chain Protein (NfL) has been found by many studies as a sensitive biomarker of neuronal damage from several reasons, e.g. neurodegenerative diseases (Alzheimer's disease, Multiple Sclerosis, etc.), inflamation (HIV) or trauma. Its role as biomarker thus offers a possibility to predict and manage diseases associated with neuronal damage. Therefore our aim is to investigate the changes in level of NfL in hydrocephalus and to find its role in management of treatment in hydrocephalus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In group A:
- •Patients with diagnosed communicating hydrocephalus
- •MMSE > 10 points
- •Absence of any structural laesion on MRI or CT
- •Accepted Informed consent
- •In group B:
- •MMSE > 10 points
- •Absence of any structural laesion on MRI or CT
- •Accepted Informed consent
- •Elective spinal surgery without affecting dural sac and the spinal cord
- •Surgery shorter than 120 minutes of lasting the general anesthesia
排除标准
- •Non-communicating hydrocephalus
- •Structural laesion on MRI or CT (tumour, contusion, aneurysm)
- •MMSE < 10 points
- •Life-expectancy shorter than 1 year
- •Pre-existing other type of demetia (m. Alzheimer, vascular dementia)
- •Surgery lasting more than 120 minutes
- •Blood loss more than 500 ml
- •Opening of dural sac (liquororhea)
- •Adverse events during general anestesia: MAP<60 mm Hg more than 5 minutes, arythmia with need for farmacological treatment
研究组 & 干预措施
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Lumbar puncture (Diagnostic Test)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: External lumbar drainage (Diagnostic Test)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Lumbar infusion test (Diagnostic Test)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Ventriculo-peritoneal shunt placement (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Prechamber puncture (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: General Anesthesia (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Blood sampling #1 (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Blood sampling #2 (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Blood sampling #3 (Procedure)
Study group A
Patients with diagnosed hydrocephalus undergoing surgery (VP shunt placement) in general anestezia. Before surgery patients undergo lumbar puncture or external lumbar drainage placement to confirmate the diagnosis and responsivity to VP shunt placement.
干预措施: Blood sampling #4 and #5 (Procedure)
Study group B
Patients without diagnosed hydrocephalus undergoing short spinal surgery without affecting dural sac (e.g. anterior cervical discectomy and fusion or lumbar disc herniation or lumbar decompression) in general anestezia.
干预措施: General Anesthesia (Procedure)
Study group B
Patients without diagnosed hydrocephalus undergoing short spinal surgery without affecting dural sac (e.g. anterior cervical discectomy and fusion or lumbar disc herniation or lumbar decompression) in general anestezia.
干预措施: Blood sampling #1 (Procedure)
Study group B
Patients without diagnosed hydrocephalus undergoing short spinal surgery without affecting dural sac (e.g. anterior cervical discectomy and fusion or lumbar disc herniation or lumbar decompression) in general anestezia.
干预措施: Blood sampling #2 (Procedure)
Study group B
Patients without diagnosed hydrocephalus undergoing short spinal surgery without affecting dural sac (e.g. anterior cervical discectomy and fusion or lumbar disc herniation or lumbar decompression) in general anestezia.
干预措施: Blood sampling #3 (Procedure)
结局指标
主要结局
Number of changes in valve settings
时间窗: 3 months after surgery
To investigate the number of changes in valve settings according the patient's clinical state based on clinical examination, CT examination or telemetrically measured CSF pressure
Recruitment rate
时间窗: 6 months
To assess the number of patients recruited in a pilot study. Recruitment rate is one of the predictor of feasibility of a study
次要结局
- Correlation between NfL level and patient's clinical state(3 months after surgery)
研究者
Miroslav Cihlo
Principal investigator
University Hospital Hradec Kralove