An observational study in Chronic Subdural Hematoma and Registry, sponsored by Erasmus Medical Center. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Erasmus Medical Center · Observational
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:
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.
112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 210 across 20 observational studies indexed under Hematoma, Subdural, Chronic.
Browse Hematoma, Subdural, Chronic studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with CSDH will be recruited from participating centers.
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Exclusion Criteria:
All adult patients diagnosed with chronic subdural hematoma who provide informed consent to participate in the study will be included. Participants will receive standard care, with treatment determined by their treating physician based on clinical judgment. Treatment options may include burr hole drainage, craniotomy, embolization of the middle meningeal artery, pharmacological management, or a wait-and-scan approach. Follow-up will be conducted at 3 months via a telephone interview.
modified 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
Plan to share: Yes — De-identified research data may be shared with third parties to enhance its scientific value. Requests for data must be submitted to the principal investigators, accompanied by a detailed description of the study's objectives and methods. Data will be available for sharing beginning in January 2028. Sharing will be permitted for scientific purposes, such as individual patient meta-analyses. Additionally, explicit consent will be required for sharing de-identified data outside the European Union.
Time frame: Data will be available for sharing beginning in January 2028.
Access criteria: Written proposals will be reviewed by the registry's principal investigators to evaluate their suitability for data use. Before any data is shared, a data-sharing agreement compliant with Dutch regulations will be established.
Started Oct 2021 (actual). Primary completion is estimated for Oct 2027, 72 months after the start.
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