Registry of Chronic Subdural Hematoma

Recruiting

• Conditions: Chronic Subdural Hematoma; Registry

• Registration Number: NCT06759428
• Lead Sponsor: Erasmus Medical Center

Brief Summary

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2024-12-29
• Study First Submitted QC: 2024-12-29
• Status Verified: 2025-01
• Study First Posted: 2025-01-06
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2027-10
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Patients diagnosed with CSDH
• 18 years or older

Exclusion Criteria

• Patients who do not consent to participate in the registry

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
modified Rankin Scale (mRS) score at 3 months following diagnosis	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.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate within 3 months following diagnosis	3 months following diagnosis	Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.
Mortality within 3 months following diagnosis	3 months following diagnosis	All-cause mortality.
Complications within 3 months following diagnosis	3 months following diagnosis	Complications after treatment of CSDH.
Duration of hospital stay	3 months following diagnosis	Total number of days admitted to the hospital for CSDH-related causes.
Markwalder Grading Scale (MGS) score at 3 months following diagnosis	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.
modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis	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.
Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis	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.

Trial Locations

Locations (2)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands