Registry of Chronic Subdural Hematoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Subdural Hematoma, Registry. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- modified Rankin Scale (mRS) score at 3 months following diagnosis [Time frame: 3 months following diagnosis]
Secondary outcome measures (7)
- Recurrence rate within 3 months following diagnosis [Time frame: 3 months following diagnosis]
- Mortality within 3 months following diagnosis [Time frame: 3 months following diagnosis]
- Complications within 3 months following diagnosis [Time frame: 3 months following diagnosis]
- Duration of hospital stay [Time frame: 3 months following diagnosis]
- Markwalder Grading Scale (MGS) score at 3 months following diagnosis [Time frame: 3 months following diagnosis]
- modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis [Time frame: 3 months following diagnosis]
- Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis [Time frame: 3 months following diagnosis]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with CSDH
- 18 years or older
Exclusion criteria
- Patients who do not consent to participate in the registry
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 2 centers
- Amsterdam UMC — Amsterdam
- Erasmus MC — Rotterdam
Identifiers
NCT: NCT06759428 · MEC-2021-0629