NCT06323434 Spinal CSF Leaks in Chronic Subdural Hematoma
| NCT ID | NCT06323434 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Freiburg |
| Condition | Chronic Subdural Hematoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 220 participants in total. It began in 2024-06-24 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Chronic subdural hematoma on imaging (CT/MRI) 2. Age: 18 years or older 3. Informed consent Exclusion Criteria: 1. General contraindications for MRI examination (e.g., pacemaker wearers, implanted insulin, or pain pump, neurostimulator, etc.) 2. Recurrent chronic subdural hematoma and previously performed diagnostics and treatment in compliance to the current cSDH SOP 3. Severe brain injury, acute subdural hematoma, epidural hematoma, subarachnoid hemorrhage
Contact & Investigator
Jürgen Beck, Prof.
PRINCIPAL INVESTIGATOR
Department of Neurosurgery, Medical Center, University of Freiburg
Frequently Asked Questions
Who can join the NCT06323434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Subdural Hematoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06323434 currently recruiting?
Yes, NCT06323434 is actively recruiting participants. Contact the research team at katharina.wolf@uniklinik-freiburg.de for enrollment information.
Where is the NCT06323434 trial being conducted?
This trial is being conducted at Freiburg im Breisgau, Germany.
Who is sponsoring the NCT06323434 clinical trial?
NCT06323434 is sponsored by University of Freiburg. The principal investigator is Jürgen Beck, Prof. at Department of Neurosurgery, Medical Center, University of Freiburg. The trial plans to enroll 220 participants.