Investigating spinal CSF leaks in patients with chronic subdural hematoma
Spinal CSF Leaks in Chronic Subdural Hematoma
This study looks at whether leaks of spinal fluid might be connected to chronic subdural hematomas in patients to help improve diagnosis and treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Freiburg Academic / other |
| Locations | 1 site (Freiburg im Breisgau, Baden-Wurttemberg) |
| Trial ID | NCT06323434 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with chronic subdural hematoma (cSDH), a condition characterized by the accumulation of blood and fluid between the brain and its outer covering. The research aims to explore the potential link between spinal cerebrospinal fluid (CSF) leaks and the development of cSDH, which is often underdiagnosed. Participants will undergo imaging studies such as CT or MRI to confirm the presence of cSDH and assess the underlying causes. The study seeks to improve understanding of cSDH and its complications, potentially leading to better diagnostic and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have been diagnosed with chronic subdural hematoma via imaging.
Not a fit: Patients with recurrent chronic subdural hematoma or those with severe brain injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of chronic subdural hematoma, ultimately enhancing patient outcomes.
How similar studies have performed: While the link between spinal CSF leaks and chronic subdural hematoma is not widely studied, there is emerging interest in this area, suggesting potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Freiburg im Breisgau, Baden-Wurttemberg
- University of Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany (Recruiting)
Study contacts
- Principal investigator: Jürgen Beck, Prof. — Department of Neurosurgery, Medical Center, University of Freiburg
- Study coordinator: Katharina Wolf, Dr.
- Email: katharina.wolf@uniklinik-freiburg.de
- Phone: +4976127093556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.