Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence of delayed cerebral ischemia
研究概览
简要总结
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).
In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
详细描述
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from a secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).
In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
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
- 否
入选标准
- •Age ≥ 18 years
- •Admitted to the Tampere University Hospital ICU due to aneurysmal SAH
- •Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
- •Definite or approximated time for the onset of symptoms and delay to ICU admission no more than 24 hours
- •Expected treatment time at least 120 hours in the Tampere University Hospital
排除标准
- •Known pregnancy
- •Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (under 150 mg/day)
- •Known active cancer or cirrhotic liver disease or end-stage renal disease requiring renal replacement therapy
结局指标
主要结局
Incidence of delayed cerebral ischemia
时间窗: 14 days
Incidence of DCI (delayed cerebral ischemia)
次要结局
- Assessment of pain(Up to 14 days)
- Assessment of cardiopulmonary function by transthoracic echocardiography(At admission and at at 24±4 hours)
- Neuroglial brain injury biomarkers(From 24 to 288 hours)
- Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis(at 72 hours)
- Continuous electroencephalography(From 48 hours to 14 days)
- Incidence of deep venous thrombosis(Within 3-7 days)
- Other rotational thromboelastometry analysis(from 24 to 288 hours)
- Assessment of neurological outcome(90 days)