Patient Registry for Patients With Chronic Subdural Hematoma

Hematoma Clinical Trial

— CSDH-R  

Official title:

Patient Registry for Patients With Chronic Subdural Hematoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04170582
• Other study ID #: 2019-569
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: January 2025

Study information

• Verified date: March 2023
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Kerim Beseoglu, MD, PhD
• Phone: 0049-211-81-08333
• Email: beseoglu[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• unilateral or bilateral chronic subdural hematoma

• patient consent

Exclusion Criteria:

• acute subdural hematoma

• no patient consent

• subdural hygroma

Related Conditions & MeSH terms

• Chronic
• Hematoma
• Hematoma, Subdural, Chronic
• Subdural Hematoma

Locations

Country	Name	City	State
Germany	Department of Neurosurgery, Heinrich-Heine-University Düsseldorf	Düsseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institut of Health Stroke Scale	Neurological condition as measured by NIHSS: This tool is used to objectively quantify neurological impairment. The score is composed of 11 items each scoring one specific ability with values between 0 and 4 points. A higher score indicates a higher level of impairment. The maximum score is 42, the minimum scor is 0 indicating no neurological impairment.	24 Month
Secondary	Montreal Cognitive Assessment	Cognitive status as measured by Montreal Cognitive Assessment (MoCA): This score is used to detect cognitive impairment.It was especially validated to detect mild cognitive dysfunction. MoCA scores range form 0 to 30 points, a score above 25 is considered to be normal.	24 month
Secondary	Short Form 12 ver. 2	Self-perceived quality of life as measured by Short Form 12 (SF-12 ver. 2): This is a shorter version of the short form 36 and is a patient-reported survey of physical and mental well-being. It consists of 12 items representing 4 physical and 4 mental domains which are aggregated into 2 summary measures: Physical Health (PCS) and Mental Health (MCS). Both scales are transformed to have a mean of 50 and a standard deviation of 10.	24 month