Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2021-10-01
2028-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CSDH patients
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Responsible Party
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R. Dammers
Principal Investigator
Principal Investigators
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Ruben Dammers
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Dagmar Verbaan
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Dagmar Verbaan
Role: primary
Rahman Fakhry
Role: primary
Ruben Dammers
Role: backup
Related Links
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Other Identifiers
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MEC-2021-0629
Identifier Type: -
Identifier Source: org_study_id
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