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临床试验/NCT02334657
NCT02334657已完成不适用

Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage

University Clinic Frankfurt0 个研究点目标入组 173 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
173
主要终点
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36

研究概览

简要总结

Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.

详细描述

Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. The blood distribution can be described as perimesencephalic/prepontine or non-perimesencephalic. Depending on the pattern of SAH the clinical course of the patients can be similar to aneurysmal SAH. In general, patients with a perimesencephalic SAH (PM-SAH) are considered to achieve good outcome and to have lower rebleeding risk. However, long-term outcome data on patients suffering from spontaneous non-aneurysmal SAH (non-aSAH) is scarce and lacking for physical and psychological outcome. Therefore, the aim of the present study was to investigate the long-term physical and psychological outcome in patients suffering from non-aneurysmal spontaneous SAH.

SAH was confirmed on computed tomography (CT) or lumbar puncture. Only patients with a non-traumatic SAH were included. In our hospital algorithm all patients with SAH underwent angiography including 3D digital subtraction angiography (DSA) since 2002 to rule out intracranial sources for SAH. In case of a negative initial angiography, DSA was repeated after 14 days. Additionally, magnetic resonance imaging (MRI) of head/spine was performed to rule out any spinal bleeding sources. In patients with blood distribution exceeding the typical perimesencephalic pattern, a third DSA was performed 3 months after SAH. The first (short-term) follow-up (F/U) was performed six months after ictus. Outcome was measured according to the modified Rankin Scale (mRS) and stratified into favorable (mRS 0-2) and unfavorable (mRS 3-6) after six months. Patients with non-aSAH were divided into perimesencephalic SAH (PM-SAH), non-perimesencephalic SAH (NPM-SAH) and excellent Outcome group (mRS 0). Also the NPM-SAH group was further stratified into Fisher 3 blood pattern and NPM-SAH without Fisher 3 blood pattern.

Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • spontaneous, non-traumatic SAH
  • SAH confirmed on computed tomography (CT) or lumbar puncture
  • negative initial and follow-up angiography
  • age: no limit

排除标准

  • traumatic SAH
  • aneurysmal SAH
  • SAH in whom other bleeding sources were identified (AVM etc.)

结局指标

主要结局

Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36

时间窗: 18months to 15 years

Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to: * non-aneurysmal SAH * PM /NPM-SAH * mRS 0 group * NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern

次要结局

  • mortality(18months to 15 years)

研究者

发起方
University Clinic Frankfurt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Konczalla

Dr. med.

University Clinic Frankfurt

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