Patient Registry for Patients With Chronic Subdural Hematoma

NCT ID: NCT04170582

Last Updated: 2023-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-01-31

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.

Conditions

Hematoma; Subdural Hematoma; Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• unilateral or bilateral chronic subdural hematoma
• patient consent

Exclusion Criteria

• acute subdural hematoma
• no patient consent
• subdural hygroma

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerim Beseoglu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty

Locations

Department of Neurosurgery, Heinrich-Heine-University Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Kerim Beseoglu, MD, PhD

Role: CONTACT

beseoglu@med.uni-duesseldorf.de

0049-211-81-08333

Franziska Staub-Bartelt, MD

Role: CONTACT

Franziska.Staub-Bartelt@med.uni-duesseldorf.de

0049-211-81-07445

Facility Contacts

Kerim Beseoglu, MD, PhD

Role: primary

beseoglu@med.uni-duesseldorf.de

0049-211-81 ext. 08333

Other Identifiers

2019-569

Identifier Type: -

Identifier Source: org_study_id