The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions: 1. What are the characteristics of patients with CSDH when they are diagnosed? 2. What treatments do patients with CSDH receive? 3. What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status? Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
Rationale: Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential. Objective: To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma. Study design: A prospective, observational multicenter cohort study. Study population: All adult patients diagnosed with chronic subdural hematoma. Main study parameters/endpoints: The primary endpoint is functional outcome, measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints, also assessed at 3 months, include recurrence, mortality, complications, hospital length of stay, Markwalder Grading Scale (MGS), modified National Institutes of Health Stroke Scale (mNIHSS), and Telephone Interview for Cognitive Status (TICS). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be treated in accordance with standard clinical practice. Study participation imposes minimal additional burden, consisting of a single telephone interview at three months, estimated to take approximately 10 minutes. The findings from this registry are expected to benefit future CSDH patients by informing evidence-based guidelines and improving care practices.
Study Type
OBSERVATIONAL
Enrollment
1,500
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGErasmus MC
Rotterdam, Netherlands
RECRUITINGmodified Rankin Scale (mRS) score at 3 months following diagnosis
Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.
Time frame: 3 months following diagnosis
Recurrence rate within 3 months following diagnosis
Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.
Time frame: 3 months following diagnosis
Mortality within 3 months following diagnosis
All-cause mortality.
Time frame: 3 months following diagnosis
Complications within 3 months following diagnosis
Complications after treatment of CSDH.
Time frame: 3 months following diagnosis
Duration of hospital stay
Total number of days admitted to the hospital for CSDH-related causes.
Time frame: 3 months following diagnosis
Markwalder Grading Scale (MGS) score at 3 months following diagnosis
Neurological outcome assessed using the Markwalder Grading Scale (MGS), a 4-point scale where 0 indicates no symptoms, higher scores reflect greater neurological disability, and 4 represents coma.
Time frame: 3 months following diagnosis
modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis
Neurological outcome assessed using the modified National Institutes of Health Stroke Scale (mNIHSS), a standardized tool ranging from 0 to 31, where 0 indicates no neurological deficits, and higher scores reflect increasing severity of stroke-related impairments.
Time frame: 3 months following diagnosis
Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis
Cognitive status assessed using the Telephone Interview for Cognitive Status (TICS), a standardized tool ranging from 0 to 50, where higher scores indicate better cognitive functioning, and lower scores reflect greater cognitive impairment.
Time frame: 3 months following diagnosis
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