Spinal CSF Leaks in Chronic Subdural Hematoma

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Freiburg

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

220 Participants
are grouped into 1 trial group
Group A: cSDH

Trial outcomes

Primary outcomes

1

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

Time frame
up to 4 weeks

Secondary outcomes

1

Number of identified CSF leak types:

* Ventral leak * Lateral leak * CSF-venous fistula * Sacral leak * Undefined

Time frame
up to 4 weeks
2

Number of diagnostic procedures performed:

* CT head * MRI head * MRI spine * Myelography

Time frame
up to 6 month
3

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

Time frame
up to 6 month
4

Color of hematoma evacuated:

* clear to amber-colored (yes/no) * "motor-oil" appearance (yes/no)

Time frame
up to 6 month

Other outcomes

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