Spinal CSF Leaks in Chronic Subdural Hematoma

NCT06323434 | Recruiting

• 1 other identifier: spice1
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Spinal CSF leak; Spontaneous Intracranial Hypotension; CSF-venous fistula

Outcome Measures

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

  up to 4 weeks

Secondary Outcomes (45)

• Number of identified CSF leak types:

  up to 4 weeks

• Number of diagnostic procedures performed:

  up to 6 month

• Number, and site of interventions needed for cSDH:

  up to 6 month

• Color of hematoma evacuated:

  up to 6 month

• Age

  at time of inclusion

Study Arms (1)

cSDH

1. Chronic subdural hematoma on imaging (CT/MRI) 2. Age: 18 years or older 3. Informed consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Chronic subdural hematoma on imaging (CT/MRI)
• Age: 18 years or older
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Freiburg: lead

Study Sites (1)

University of Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Related Publications (22)

• Beck J, Gralla J, Fung C, Ulrich CT, Schucht P, Fichtner J, Andereggen L, Gosau M, Hattingen E, Gutbrod K, Z'Graggen WJ, Reinert M, Husler J, Ozdoba C, Raabe A. Spinal cerebrospinal fluid leak as the cause of chronic subdural hematomas in nongeriatric patients. J Neurosurg. 2014 Dec;121(6):1380-7. doi: 10.3171/2014.6.JNS14550. Epub 2014 Jul 18.

  PMID: 25036203 BACKGROUND

• Dobrocky T, Grunder L, Breiding PS, Branca M, Limacher A, Mosimann PJ, Mordasini P, Zibold F, Haeni L, Jesse CM, Fung C, Raabe A, Ulrich CT, Gralla J, Beck J, Piechowiak EI. Assessing Spinal Cerebrospinal Fluid Leaks in Spontaneous Intracranial Hypotension With a Scoring System Based on Brain Magnetic Resonance Imaging Findings. JAMA Neurol. 2019 May 1;76(5):580-587. doi: 10.1001/jamaneurol.2018.4921.

  PMID: 30776059 BACKGROUND

• Dumont TM, Rughani AI, Goeckes T, Tranmer BI. Chronic subdural hematoma: a sentinel health event. World Neurosurg. 2013 Dec;80(6):889-92. doi: 10.1016/j.wneu.2012.06.026. Epub 2012 Jun 19.

  PMID: 22722034 BACKGROUND

• Edlmann E, Giorgi-Coll S, Whitfield PC, Carpenter KLH, Hutchinson PJ. Pathophysiology of chronic subdural haematoma: inflammation, angiogenesis and implications for pharmacotherapy. J Neuroinflammation. 2017 May 30;14(1):108. doi: 10.1186/s12974-017-0881-y.

  PMID: 28558815 BACKGROUND

• El Rahal A, Beck J, Ahlborn P, Bernasconi C, Marbacher S, Wanderer S, Burkhardt JK, Daniel RT, Ferrari A, Hausmann O, Kamenova M, Kothbauer K, Lutz K, Mariani L, Alfieri A, Schoni D, Schucht P, Raabe A, Regli L, Kuhlen D, Seule M, Soleman J, Starnoni D, Zaldivar J, Zweifel C, Schaller K, Fung C. Incidence, therapy, and outcome in the management of chronic subdural hematoma in Switzerland: a population-based multicenter cohort study. Front Neurol. 2023 Sep 14;14:1206996. doi: 10.3389/fneur.2023.1206996. eCollection 2023.

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  PMID: 32593768 BACKGROUND

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  PMID: 35236548 BACKGROUND

• Hufschmidt, A., S. Rauer, F. Glocker, and Hrsg, eds. 2022. Neurologie compact. Stuttgart: Thieme und doi:10.1055/b000000096

  BACKGROUND

• Kim HJ, Lee JW, Lee E, Kang Y, Ahn JM. Incidence of Spinal CSF Leakage on CT Myelography in Patients with Nontraumatic Intracranial Subdural Hematoma. Diagnostics (Basel). 2021 Dec 6;11(12):2278. doi: 10.3390/diagnostics11122278.

  PMID: 34943515 BACKGROUND

• Kranz PG, Malinzak MD, Gray L, Willhite J, Amrhein TJ. Resisted Inspiration Improves Visualization of CSF-Venous Fistulas in Spontaneous Intracranial Hypotension. AJNR Am J Neuroradiol. 2023 Aug;44(8):994-998. doi: 10.3174/ajnr.A7927. Epub 2023 Jul 6.

  PMID: 37414450 BACKGROUND

• Lutzen N, Aleman EB, El Rahal A, Volz F, Fung C, Beck J, Urbach H. Sacral Dural Tears as a Cause of Spontaneous Intracranial Hypotension. Clin Neuroradiol. 2023 Dec;33(4):957-964. doi: 10.1007/s00062-023-01292-0. Epub 2023 Jun 1.

  PMID: 37261452 BACKGROUND

• Lutzen N, Beck J, Urbach H. Cerebrospinal Fluid Venous Fistula Imaging with Ultrahigh-Resolution Cone-Beam Computed Tomography. JAMA Neurol. 2023 Aug 1;80(8):870-871. doi: 10.1001/jamaneurol.2023.1640.

  PMID: 37306975 BACKGROUND

• Mehta V, Harward SC, Sankey EW, Nayar G, Codd PJ. Evidence based diagnosis and management of chronic subdural hematoma: A review of the literature. J Clin Neurosci. 2018 Apr;50:7-15. doi: 10.1016/j.jocn.2018.01.050. Epub 2018 Feb 7.

  PMID: 29428263 BACKGROUND

• Miah IP, Holl DC, Blaauw J, Lingsma HF, den Hertog HM, Jacobs B, Kruyt ND, van der Naalt J, Polinder S, Groen RJM, Kho KH, van Kooten F, Dirven CMF, Peul WC, Jellema K, Dammers R, van der Gaag NA; DECSA Collaborators. Dexamethasone versus Surgery for Chronic Subdural Hematoma. N Engl J Med. 2023 Jun 15;388(24):2230-2240. doi: 10.1056/NEJMoa2216767.

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• Schievink WI, Maya MM, Barnard ZR, Moser FG, Jean-Pierre S, Waxman AD, Nuno M. Behavioral Variant Frontotemporal Dementia as a Serious Complication of Spontaneous Intracranial Hypotension. Oper Neurosurg. 2018 Nov 1;15(5):505-515. doi: 10.1093/ons/opy029.

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• Schievink WI, Maya MM, Harris J, Galvan J, Tache RB, Nuno M. Infratentorial Superficial Siderosis and Spontaneous Intracranial Hypotension. Ann Neurol. 2023 Jan;93(1):64-75. doi: 10.1002/ana.26521. Epub 2022 Oct 22.

  PMID: 36200700 BACKGROUND

• Schievink WI, Maya MM, Pikul BK, Louy C. Spontaneous spinal cerebrospinal fluid leaks as the cause of subdural hematomas in elderly patients on anticoagulation. J Neurosurg. 2010 Feb;112(2):295-9. doi: 10.3171/2008.10.JNS08428.

  PMID: 19199465 BACKGROUND

• Schievink WI, Moser FG, Maya MM. CSF-venous fistula in spontaneous intracranial hypotension. Neurology. 2014 Jul 29;83(5):472-3. doi: 10.1212/WNL.0000000000000639. Epub 2014 Jun 20. No abstract available.

  PMID: 24951475 BACKGROUND

• Takahashi K, Mima T, Akiba Y. Chronic Subdural Hematoma Associated with Spontaneous Intracranial Hypotension: Therapeutic Strategies and Outcomes of 55 Cases. Neurol Med Chir (Tokyo). 2016;56(2):69-76. doi: 10.2176/nmc.oa.2015-0032. Epub 2015 Oct 21.

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  PMID: 28325454 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Cerebrospinal Fluid Otorrhea; Intracranial Hypotension

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries; Cerebrospinal Fluid Leak; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jürgen Beck, Prof.

  Department of Neurosurgery, Medical Center, University of Freiburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina Wolf, Dr.

CONTACT

+4976127093556; katharina.wolf@uniklinik-freiburg.de

Florian Volz, Dr.

CONTACT

+4976127093556; florian.volz@uniklinik-freiburg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: March 21, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)