Clinical trial NCT04170582: Patient Registry for Patients With Chronic Subdural Hematoma
Official title: Patient Registry for Patients With Chronic Subdural Hematoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hematoma
Subdural Hematoma
Chronic
Keywords: Hemorrhage
Subdural
Chronic Subdural Hematoma
Chronic
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic subdural hematomas (cSDH) are a very common pathological entity particularly in the western countries with an aging population. The estimated incidence in older patients is roughly 300/100,000, which is in contrast to the general incidence of less than 20 per 100,000.

cSDH patients represent a relevant portion of all patients referred to neurosurgical departments.

The prognosis of cSDH is generally considered to be good even when surgical intervention is required, however cSDH may still result in significant patient mortality and morbidity.

Brief summary: All admitted patients diagnosed with unilateral or bilateral chronic subdural hematoma are included into this registry after consent. Clinical condition, radiological details, therapy (intervention/medication treatment/conservative) and outcome are documented. Patient follow-up is documented over at least 24 month with focus on neurological condition (NIHSS), cognitive impairment (MoCA) and quality of life (SF-12 ver. 2).

Detailed description: Chronic subdural hematoma (cSDH) is a frequent disease in- predominantly - elderly patients often caused by minor trauma to the bridging veins eventually leading to a collection of old blood in the subdural space over time. Besides age of the patients a number of further risk factors are assumed to favor pathogenesis. Depending on size and location of blood collections diverse neurological symptoms can be seen. Therapy approaches are heterogeneous ranging from conservative treatment with or without medication to surgical treatment. There also is lacking knowledge regarding neurocognitive impairment and effects on quality of life in patients under different therapy regimes.

The prospective patient registry will enclose all patients admitted to the investigator's department diagnosed with cSDH either by MRI or CT scan after informed consent. Medical history, regular medication, social status, radiological findings and neurological examination using NIHSS will be performed at time of inclusion, discharge and follow-up. Additionally, neurocognitive testing and documentation of Quality of Life using MOCA Test and SF-12 will be conducted at different timepoints. Moreover a detailed documentation of therapy strategies is implemented in the study protocol.

With this registry the study group expects to obtain significant data leading to a more standardized and optimized therapy regime and furthermore widening understanding on so far rarely known impact of cSDH on neurocognition and quality of life.

Eligibility criteria: Inclusion Criteria:

* unilateral or bilateral chronic subdural hematoma
* patient consent

Exclusion Criteria:

* acute subdural hematoma
* no patient consent
* subdural hygroma

Primary outcomes:
measure: National Institut of Health Stroke Scale
timeFrame: 24 Month
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 24 month
measure: Short Form 12 ver. 2
timeFrame: 24 month
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Department of Neurosurgery, Heinrich-Heine-University Düsseldorf
state: NRW
Study officials:
affiliation: Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty
name: Kerim Beseoglu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: