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NCT Number: NCT06759428

Registry of Chronic Subdural Hematoma

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.

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Registry Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, Amsterdam, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with CSDH
  • 18 years or older

Exclusion criteria

  • Patients who do not consent to participate in the registry

Treatment and study plan

Primary outcomes

  1. modified Rankin Scale (mRS) score at 3 months following diagnosis

    Time frame: 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 outcomes

  1. Recurrence rate within 3 months following diagnosis

    Time frame: 3 months following diagnosis

    Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.

  2. Mortality within 3 months following diagnosis

    Time frame: 3 months following diagnosis

    All-cause mortality.

  3. Complications within 3 months following diagnosis

    Time frame: 3 months following diagnosis

    Complications after treatment of CSDH.

  4. Duration of hospital stay

    Time frame: 3 months following diagnosis

    Total number of days admitted to the hospital for CSDH-related causes.

  5. Markwalder Grading Scale (MGS) score at 3 months following diagnosis

    Time frame: 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.

  6. modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis

    Time frame: 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.

  7. Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dana C. Holl

CONTACT

[email protected]

Rahman Fakhry

CONTACT

[email protected]

+31 10 7043507

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: CSDH Registry

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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