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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Amsterdam UMC
Amsterdam, Netherlands
Erasmus MC
Rotterdam, Netherlands
Start Date
October 1, 2021
Primary Completion Date
October 1, 2027
Completion Date
January 1, 2028
Last Updated
January 7, 2025
1,500
ESTIMATED participants
Lead Sponsor
Erasmus Medical Center
NCT06163547
NCT05374681
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07324551