About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chronic subdural hematoma on imaging (CT/MRI)
Age: 18 years or older
Informed consent
Disqualifiers
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
Trial population
All patients admitted to the Department of Neurosurgery with cSDH on imaging will be approached and informed about the study after initial treatment of the intracranial hemorrhage if indicated. In case of legal incapacity, the designated caregiver and legal council will be approached for consent. The inclusion of this vulnerable group is considerable as they represent an important subgroup of patients. Otherwise, the trial would not be suitable to represent a typical patient cohort, and data would not be meaningful for clinical standards. The inclusion of vulnerable groups seems justifiable as there will be no additional procedure performed other than clinical standard work-up.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
evidence of a spinal CSF leak (yes/no)
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
Secondary outcomes
Number of identified CSF leak types:
* Ventral leak * Lateral leak * CSF-venous fistula * Sacral leak * Undefined
Number of diagnostic procedures performed:
* CT head * MRI head * MRI spine * Myelography
Number, and site of interventions needed for cSDH:
* Twist drill trephination * Twist drill trephination with drain * Conventional trepanation * Twist drill trephination or conventional trepanation with drain and any form of controlled lavage (saline and or clot lysis) * Embolisation of media meningeal artery
Color of hematoma evacuated:
* clear to amber-colored (yes/no) * "motor-oil" appearance (yes/no)
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