Clinical trial NCT06759428: Registry of Chronic Subdural Hematoma
Official title: Registry of Chronic Subdural Hematoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Subdural Hematoma
Registry
Keywords: Chronic subdural hematoma
Traumatic Brain Injury
Registry
Treatment outcome
Burr hole drainage
modified Rankin Scale
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with CSDH will be recruited from participating centers.

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.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with CSDH
* 18 years or older

Exclusion Criteria:

* Patients who do not consent to participate in the registry

Primary outcomes:
measure: modified Rankin Scale (mRS) score at 3 months following diagnosis
timeFrame: 3 months following diagnosis
Secondary outcomes:
measure: Recurrence rate within 3 months following diagnosis
timeFrame: 3 months following diagnosis
measure: Mortality within 3 months following diagnosis
timeFrame: 3 months following diagnosis
measure: Complications within 3 months following diagnosis
timeFrame: 3 months following diagnosis
measure: Duration of hospital stay
timeFrame: 3 months following diagnosis
measure: Markwalder Grading Scale (MGS) score at 3 months following diagnosis
timeFrame: 3 months following diagnosis
measure: modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis
timeFrame: 3 months following diagnosis
measure: Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis
timeFrame: 3 months following diagnosis
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Rotterdam
country: Netherlands
facility: Erasmus MC
Study officials:
affiliation: Erasmus Medical Center
name: Ruben Dammers
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Dagmar Verbaan
role: PRINCIPAL_INVESTIGATOR
References: