Spinal CSF Leaks in Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- evidence of a spinal CSF leak (yes/no)
研究概览
简要总结
Background: Chronic subdural hematoma (cSDH) is a type of intracranial bleeding, predominantly affecting the elderly and males, with an estimated incidence of 8/100.000. The collection of subdural fluid expands slowly, leading eventually to brain tissue compression that results in neurological impairment such as seizures, cognitive decline, and paresis. Most patients need neurosurgical evacuation of the blood to improve and to prevent further, possibly permanent deterioration. Evidently, the cause of such a bleeding must be investigated and if possible treated, or preventive strategies need to be installed if possible. Spinal cerebrospinal fluid (CSF) leaks are a known cause of cSDH but are widely underdiagnosed in this population.
The spinal CSF leak causes CSF loss that leads to intracranial hypotension, expansion of intracerebral veins, and traction to the brain and the surrounding tissues. A cSDH is a severe complication of such a leak and occurs in about 30% of all cases with a predominance among the elderly. It is crucial to identify these patients with a spinal leak as treatment pathways differ essentially from patients without a leak. Some smaller studies indicated a prevalence of spinal CSF leaks among cSDH patients of 30% to 80% depending on selection criteria (age, extend of cSDH). Notably, the entity of the CSF-venous fistula, that has been discovered as recent as 9 years ago, and that by now is accounting for 20-25% of all spinal leaks, has not been considered in previous research on cSDH and spinal CSF leaks.
Currently, there is no prospective data on spinal CSF leaks in patients with cSDH. Establishment of such data is crucial to improve diagnostic and therapeutic algorithms for spinal CSF leaks in patients with cSDH.
Objective: To prospectively assess the prevalence of spinal CSF leaks in patients with cSDH Methods: This is a prospective observational, monocentric study on patients admitted due to cSDH to the Department of Neurosurgery at the Medical Center of the University of Freiburg. Treatment and diagnostic procedures will follow standard protocols. The number of spinal CSF leaks will be assessed to generate the prevalence of spinal CSF leaks in this patient cohort. Furthermore, clinical data, the specific type of the CSF leak, and imaging parameters are assessed systematically to estimate the diagnostic value of these measures.
详细描述
Background:
Chronic subdural hematoma (cSDH) refers to a blood- and fluid-collection between the brain and the dura that is most common in the elderly with a male predominance. Patients present with headaches, gait instabilities, cognitive impairments, decline of vigilance, hemiparesis, aphasia, or seizures. These symptoms usually lead to hospital admission where the diagnosis can be easily depicted by non-contrast computer tomography (CT), or magnetic resonance imaging (MRI). Image characteristics of the transformed hemoglobin of the blood indicate the chronicity, therefore, the rather slow development of this intracranial hemorrhage. Smaller parts of acute bleeding can attribute to a faster progression. Incidence across all ages is reported at about 8/100.000, while age-depended incidence increases up to 64/100.000 at age of > 79 years. About 2/3 present with unilateral, 1/3 with bilateral hematoma.
A symptomatic cSDH requires surgical treatment, which might range from twist drill trepanation with or without drain to open trepanation and fluid evacuation in order to prevent permanent brain damage and further deterioration. Recurrence rates are up to 20%. The mortality rate is increased even after successful treatment of the bleeding.
The actual cause for the development of cSDH is yet not sufficiently explored. While a history of minor head trauma is often reported as the leading cause of cSDH, a minor trauma cannot account for the entire pathology in cSDH. Some mechanisms are reported that are rather believed to maintain but not to initiate the process: Characteristic membranes are built that are thought to cause further exudation and hemorrhage. Fragile vessels are discussed to contribute to the process, stimulated by inflammation and poor angiogenesis. Recent efforts to therapeutically address inflammation as a primary target failed, which highlights the critical need of improved therapies.
Over the past years, it has become evident, yet widely neglected in clinical daily life, that many cases of cSDH are caused by spinal cerebro spinal fluid (CSF) leaks that lead to spontaneous intracranial hypotension (SIH). These leaks lead to a continuous loss of CSF, which therefore causes hypotension and traction within the skull that is most sever in upright position. This intracranial hypotension can lead to the development of cSDH.
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
- •Chronic subdural hematoma on imaging (CT/MRI)
- •Age: 18 years or older
- •Informed consent
排除标准
- •General contraindications for MRI examination (e.g., pacemaker wearers, implanted insulin, or pain pump, neurostimulator, etc.)
- •Recurrent chronic subdural hematoma and previously performed diagnostics and treatment in compliance to the current cSDH SOP
- •Severe brain injury, acute subdural hematoma, epidural hematoma, subarachnoid hemorrhage
结局指标
主要结局
evidence of a spinal CSF leak (yes/no)
时间窗: up to 4 weeks
The primary endpoint is evidence of a spinal CSF leak (yes/no) in patients with chronic subdural hematoma (cSDH) depicted by MRI: evidence spinal longitudinal extradural fluid (SLEC), or Myelogram: detection of spinal CSF leak
次要结局
- Anti-platelet therapy intake(up to 6 months)
- Lipid regulation medication intake(up to 6 months)
- Color of hematoma evacuated:(up to 6 month)
- Number of identified CSF leak types:(up to 4 weeks)
- Number of diagnostic procedures performed:(up to 6 month)
- body weight(at time of inclusion)
- Immunotherapeutic medication intake(up to 6 months)
- Number, and site of interventions needed for cSDH:(up to 6 month)
- Karnofsky Index(up to 6 months)
- Anticoagulation intake(up to 6 months)
- Body mass index (BMI)(at time of inclusion)
- Blood pressure medication intake(up to 6 months)
- national institutes of health stroke scale (NIHSS)(up to 6 months)
- Modified Rankin Scale (mRS)(up to 6 months)
- complaints(up to 6 months)
- maximum duration being continuously upright(up to 6 months)
- severeness of hearing disturbances and tinnitus(up to 6 months)
- severeness of cognitive deficits(up to 6 months)
- Age(at time of inclusion)
- body height(at time of inclusion)
- sex(at time of inclusion)
- other medication intake(up to 6 months)
- gait disorder(up to 6 months)
- ability to focus and concentrate(up to 6 months)
- Hormonal regulation medication intake(up to 6 months)
- history of trauma(up to 6 months)
- Self-Administered Comorbidity Questionnaire (SCQ)(up to 6 months)
- current working capacity,(up to 6 months)
- severeness of dizziness(up to 6 months)
- 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale(up to 6 months)
- Headache-Impact-Test (HIT)-6(up to 6 months)
- headache severity(up to 6 months)
- Days within the last month(up to 6 months)
- Severeness of shoulder- and neck pain(up to 6 months)
- severeness of nausea(up to 6 months)
- severeness of visual disturbances(up to 6 months)
- exhaustion(up to 6 months)
- Bern-Score according to Dobrocky et al(up to 6 month)
- Patient's Global Impression of Change (PGIC)(up to 6 months)
- 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index(up to 6 months)
- Hematocrit(up to 2 days)
- Size of the chronic subdural hematoma(up to 6 month)
- Volumetry of the cranial compartments(up to 6 month)
- Spinal longitudinal extradural fluid collection (SLEC)(up to 6 month)
- DiverTICula (TIC)(up to 6 month)
研究者
Katharina Wolf
Clinician Scientist
University of Freiburg