The Pathogenesis of Terson Syndrome and the Role of CSF Tau / Amyloid-ß 40 and 42 in Patients With Aneurysmatic Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intracranial pressure (ICP) in mmH20
研究概览
简要总结
Prospective clinical study to investigate the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-protein and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoid hemorrhage. Our two hypotheses are as follows:
- The incidence of Terson syndrome correlates with the initial intracranial opening pressure (measured with extra ventricular drain)
- The CSF-biomarkers correlate with the outcome assessed at discharge, 3-, 6- and 12-months postictally using Glasgow-Outcome-Scale-Extended (GOSE) and Euro-Qol-5 as well as with complications related to aneurysmatic subarachnoid hemorrhage such as cerebral vasospasm, delayed cerebral ischemia and re-bleed.
详细描述
In this prospective clinical study the pathogenesis of Terson syndrome and the prognostic value of the CSF-biomarkers tau-proteine and amyloid-β 40 and 42 in patients with aneurysmatic subarachnoidal hemorrhage are investigated. Intracranial opening pressure will be measured in patients requiring CSF-diversion for acute hydrocephalus and correlated with the incidence of Terson syndrome tested by an opthalmologic exam (group A: Terson syndrome positive, group B: Terson syndrome negative). CSF samples from external ventricular drainages are obtained at day 0, 2 and 6 and concentration of tau-protein and amyloid-β 40 and 42 are determined and correlated to secondary outcome measures such as delayed cerebral ischemia, clinical vasospasm, re-bleed, necessity for surgical intervention secondary to raised intracranial pressure or CSF-diversion. Outcome in terms of Glasgow-Outcome-Scale-Extended and Euro-Qol-5 will be assessed at 3, 6 and 12 months.
CSF from patients undergoing diagnostic or therapeutic tapping of their internal ventricles for normal pressure hydrocephalus or shunt diagnostics serve as a reference for CSF-biomarkers concentration in healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •older than 18 years
- •diagnosis of subarachnoid hemorrhage secondary to an intracranial aneurysm
- •aneurysmatic subarachnoid hemorrhage must be the principal diagnosis for hospitalization
- •an intracranial aneurysm must be confirmed by imaging (Computed tomography, magnet resonance tomography or angiography)
- •Patients requiring diagnostic/therapeutic tapping of their internal ventricles for CSF-diversion (shunt) for normal pressure hydrocephalus or shunt diagnostics serve as a control group
- •informed consent
排除标准
- •younger than 18 years
- •other diagnosis such as traumatic or perimesencephalic subarachnoid hemorrhage without an intracranial aneurysm
结局指标
主要结局
Intracranial pressure (ICP) in mmH20
时间窗: after insertion of EVD or ICP-probe (between day 0 and 3)
Initial ICP is measured in mmH20 after insertion of EVD with a riser tube or after insertion of an ICP-probe.
次要结局
- Delayed cerebral ischemia(Daily for the duration of hospital stay, an expected average of 3 to 5 weeks)
- Clinically manifest vasospasm(Daily for the duration of hospital stay, an expected average of 3 to 5 weeks)
- Concentration of CSF-protein phospho-tau(Day 0, 2, 6)
- Re-bleed(Daily for the duration of hospital stay, an expected average of 3 to 5 weeks)
- Concentration of CSF-protein amyloid-ß 40/42(Day 0, 2, 6)
- Necessity of CSF-shunt(Daily for the duration of hospital stay, an expected average of 3 to 5 weeks)
- Opthalmologic exam(Day 0 to 3; before discharge if initial exam negative)
- Surgery for refractory ICP (decompressive hemicraniectomy)(Daily for the duration of hospital stay, an expected average of 3 to 5 weeks)
研究者
Holger Joswig
Dr. med.
Cantonal Hospital of St. Gallen