Impact of Delayed Cerebral Ischemia (DCI) on the Neuropsychological Outcome After Aneurysmal Subarachnoid Hemorrhage - a SWISS SOS Multicentre Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Neuropsychological deterioration on the MoCA
研究概览
简要总结
The primary objective of this multicenter observational study is to determine the effect size of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months after aSAH.
Secondary objectives are the feasibility to administer and the validity of the MoCA in an intensive care unit setting, as well as the test/retest reliability of the MoCA in patients with acute brain damage in absence of aSAH.
详细描述
Background and rationale:
Delayed cerebral ischemia (DCI) is the independent most important predictor of neurological disability in survivors following aneurysmal subarachnoid hemorrhage (aSAH). DCI could also be identified as the most important predictor of moderate to severe neuropsychological impairment following aSAH. Only few prospective studies so far specifically analyzed the effect size of the relationship between DCI and neuropsychological impairment, and all studies had a methodological weakness: lack of a baseline neuropsychological assessment before the onset of DCI.
In studies analyzing the neuropsychological outcome after aSAH, the Montreal Cognitive Assessment (MoCA) is the most comprehensive, sensitive and specific instrument among the short tests. The MoCA is increasingly used in the aSAH population, while its validity and reliability has only been demonstrated in the normal population or patients suffering from diseases different from aSAH, such as e.g. Parkinson's disease or dementia. Today, neuropsychological examinations find entry into clinical routine for aSAH patients to estimate the need for inpatient rehabilitation. However, the MoCA is often applied to aSAH patients in a busy intensive or intermediate care unit, while it remains largely unknown whether the distraction in such an environment represents a bias to the obtained results.
This study therefore evaluates aSAH patients before and after the phase of DCI, as well as three months after aSAH, in order to estimate the impact of DCI on neuropsychological impairment. In addition, the extent and location of cerebral ischemia, as measured with the Alberta Stroke Program Early CT Score (ASPECTS) is correlated with the neuropsychological outcome.
Furthermore, the study measures the test/retest reliability of the MoCA, as well as the influence of the intensive care environment on the MoCA results in a randomized fashion in subjects with acute brain damage (and no aSAH).
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
- •For part 1 of the study:
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Consent of the patient or consent of patient's next of kin (plus consent of an independent physician if patient is unable to consent)
- •Aneurysmal SAH
- •Time of aSAH known (IMPORTANT: at least approximated. Time of aSAH refers to the bleed that lead to hospital admission; warning leaks in the patient history are not considered aSAH in this context)
- •Complete aneurysm occlusion therapy within 48h after aSAH
- •Glasgow coma scale (GCS) ≥ 13 points at time point 48h - 72h after aSAH
- •Fluent language skills in either English, German, French, or Italian
- •For part 2 of the study:
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Consent of the patient or consent of patient's next of kin (plus consent of an independent physician if patient is unable to consent)
- •Acute brain injury that requires a in-patient treatment, e.g. for (surgical) treatment of a brain tumor, a cerebral hemorrhage, a hydrocephalus, stroke, or traumatic brain injury, with stable neurological and general health status
- •Glasgow coma scale (GCS) ≥ 13 points
- •Fluent language skills in either English, German, French, or Italian
排除标准
- •For part 1 of the study:
- •The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- •SAH due to any other cause than aneurysm or structural abnormality of the brain (arterio-venous malformation, dural arterio-venous fistula, cavernous malformation, dissection, tumor, trauma)
- •Comatose patients or patients with a reduced vigilance of GCS < 13 at time point 48h - 72h after aSAH
- •No aneurysm occlusion therapy within 48h after aSAH
- •Clear signs of arterial vasospasm in the initial (CT-)angiography; indicating that aSAH had occurred already several days prior to admission
- •Neurologic or psychiatric diseases other than aSAH that can potentially influence the test-performance of a patient on the MoCA (e.g., dementia, multiple sclerosis, bipolar disorder)
- •Foreseeable difficulties in follow-up due to geographic reasons (e.g., patients living abroad)
- •Patients who are not fluent in English, German, French, or Italian
- •Patients requiring sedative or other medication that would interfere with the neuropsychological evaluation
- •For part 2 of the study:
- •The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- •Instable neurological or general health-status of the patient, that makes a transport of the patient on the ICU or the office for neuropsychological testing impossible
- •Suspected fluctuation of the neurological condition and the vigilance of the patient between first and second testing
- •Known psychiatric disease that can potentially influence the test-performance on the MoCA (e.g., dementia, bipolar disorder)
- •Patients who are not fluent in English, German, French, or Italian
- •Patients requiring sedative or other medication that would interfere with the neuropsychological evaluation
结局指标
主要结局
Neuropsychological deterioration on the MoCA
时间窗: 3 months after Subarachnoid Hemorrhage
The primary endpoint is the in-subject difference of the MoCA before (48-72h after aSAH) and after the active phase of DCI (3 months after aSAH) between patients with and without DCI. The MoCA scores will be assessed by a neuropsychologist, not involved in the treatment of the patient and unaware of the patient's study group assignment (DCI vs. non-DCI).
次要结局
- Shunt dependency (ventriculo-peritoneal or ventriculo-atrial shunt)(3 months after Subarachnoid Hemorrhage)
- Dependency/Mortality(3 months after Subarachnoid Hemorrhage)
- Correlation between MoCA and CT-imaging(3 months after Subarachnoid Hemorrhage)
- Neuropsychological deterioration on the MoCA(Up to 28 days after Subarachnoid Hemorrhage (directly after the DCI phase))
- Neuropsychological outcome(Up to 3 months after Subarachnoid Hemorrhage)
- Reliability of the MoCA in patients with acute brain injury(Up to 1 month following acute brain injury)
- Test-retest reliability of the MoCA in patients with acute brain injury(Up to 1 month following acute brain injury)
- Health-related quality of life (HRQoL)(3 months after Subarachnoid Hemorrhage)
- Home time(3 months after Subarachnoid Hemorrhage)
- Minimum Clinically Important Difference (MCID) of the MoCA(Up to 3 months after Subarachnoid Hemorrhage)