protocolSection identificationModule nctId: NCT06323434, orgStudyIdInfo id: spice1, briefTitle: Spinal CSF Leaks in Chronic Subdural Hematoma, acronym: SPICE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-04, completionDateStruct date: 2026-10, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: University of Freiburg, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Chronic Subdural Hematoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 220, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: evidence of a spinal CSF leak (yes/no), secondaryOutcomes measure: Number of identified CSF leak types:, secondaryOutcomes measure: Number of diagnostic procedures performed:, secondaryOutcomes measure: Number, and site of interventions needed for cSDH:, secondaryOutcomes measure: Color of hematoma evacuated:, secondaryOutcomes measure: Age, secondaryOutcomes measure: body height, secondaryOutcomes measure: body weight, secondaryOutcomes measure: Body mass index (BMI), secondaryOutcomes measure: sex, secondaryOutcomes measure: Karnofsky Index, secondaryOutcomes measure: Anti-platelet therapy intake, secondaryOutcomes measure: Anticoagulation intake, secondaryOutcomes measure: Blood pressure medication intake, secondaryOutcomes measure: Lipid regulation medication intake, secondaryOutcomes measure: Hormonal regulation medication intake, secondaryOutcomes measure: Immunotherapeutic medication intake, secondaryOutcomes measure: other medication intake, secondaryOutcomes measure: history of trauma, secondaryOutcomes measure: national institutes of health stroke scale (NIHSS), secondaryOutcomes measure: gait disorder, secondaryOutcomes measure: Modified Rankin Scale (mRS), secondaryOutcomes measure: Headache-Impact-Test (HIT)-6, secondaryOutcomes measure: current working capacity,, secondaryOutcomes measure: complaints, secondaryOutcomes measure: headache severity, secondaryOutcomes measure: Days within the last month, secondaryOutcomes measure: maximum duration being continuously upright, secondaryOutcomes measure: severeness of dizziness, secondaryOutcomes measure: Severeness of shoulder- and neck pain, secondaryOutcomes measure: severeness of nausea, secondaryOutcomes measure: severeness of hearing disturbances and tinnitus, secondaryOutcomes measure: severeness of cognitive deficits, secondaryOutcomes measure: severeness of visual disturbances, secondaryOutcomes measure: exhaustion, secondaryOutcomes measure: ability to focus and concentrate, secondaryOutcomes measure: Patient's Global Impression of Change (PGIC), secondaryOutcomes measure: Self-Administered Comorbidity Questionnaire (SCQ), secondaryOutcomes measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) Index, secondaryOutcomes measure: 5 dimension / 5 levels European Quality of life questionnaire (EQ-5D-5L) visual analogue scale, secondaryOutcomes measure: Hematocrit, secondaryOutcomes measure: Size of the chronic subdural hematoma, secondaryOutcomes measure: Volumetry of the cranial compartments, secondaryOutcomes measure: Bern-Score according to Dobrocky et al, secondaryOutcomes measure: Spinal longitudinal extradural fluid collection (SLEC), secondaryOutcomes measure: DiverTICula (TIC), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Freiburg, city: Freiburg, state: Baden-Württemberg, zip: 79106, country: Germany, contacts name: Katharina Wolf, Dr., role: CONTACT, phone: +4076127093556, email: katharina.wolf@uniklinik-freiburg.de, contacts name: Jürgen Beck, Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Amir El Rahal, Dr., role: SUB_INVESTIGATOR, contacts name: Niklas Lützen, Dr., role: SUB_INVESTIGATOR, contacts name: Horst Urbach, Prof., role: SUB_INVESTIGATOR, contacts name: Mukesch J Shah, Dr., role: SUB_INVESTIGATOR, contacts name: Christian Taschner, Prof., role: SUB_INVESTIGATOR, contacts name: Marco Reisert, Dr., role: SUB_INVESTIGATOR, contacts name: Manou Overstijns, role: SUB_INVESTIGATOR, contacts name: Katharina Wolf, Dr., role: SUB_INVESTIGATOR, contacts name: Florian Volz, Dr., role: SUB_INVESTIGATOR, geoPoint lat: 47.9959, lon: 7.85222, hasResults: False