Registry of Chronic Subdural Hematoma (CSDH Registry)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Subdural Hematoma; Registry

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

• Study Contact: Name: Rahman Fakhry; Phone Number: +31 10 7043507; Email: r.fakhry@erasmusmc.nl
• Study Contact Backup: Name: Dana C. Holl; Email: d.holl@erasmusmc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Dagmar Verbaan
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Rahman Fakhry
    • Contact: Ruben Dammers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with CSDH will be recruited from participating centers.

Description

Inclusion Criteria:

• Patients diagnosed with CSDH
• 18 years or older

Exclusion Criteria:

• Patients who do not consent to participate in the registry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months following diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate within 3 months following diagnosis	Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.	3 months following diagnosis
Mortality within 3 months following diagnosis	All-cause mortality.	3 months following diagnosis
Complications within 3 months following diagnosis	Complications after treatment of CSDH.	3 months following diagnosis
Duration of hospital stay	Total number of days admitted to the hospital for CSDH-related causes.	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.	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.	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.	3 months following diagnosis

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Investigators: Principal Investigator: Ruben Dammers, Erasmus Medical Center; Principal Investigator: Dagmar Verbaan, Amsterdam UMC

Publications and helpful links

Helpful Links

• This link provides access to the official website of the study, offering a description of the project, including its objectives, methodology, and relevant details.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Registry; Treatment outcome; Traumatic Brain Injury; modified Rankin Scale; Chronic subdural hematoma; Burr hole drainage
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
• Other Study ID Numbers: MEC-2021-0629

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available for sharing beginning in January 2028.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No