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CSDH-R: Patient Registry for Patients With Chronic Subdural Hematoma

Sponsor
Heinrich-Heine University, Duesseldorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04170582
Collaborator
(none)
250
Enrollment
1
Location
60
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient Registry for Patients With Chronic Subdural Hematoma
    Actual Study Start Date :
    Jan 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Jan 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. National Institut of Health Stroke Scale [24 Month]

      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.

    Secondary Outcome Measures

    1. Montreal Cognitive Assessment [24 month]

      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.

    2. Short Form 12 ver. 2 [24 month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • unilateral or bilateral chronic subdural hematoma

    • patient consent

    Exclusion Criteria:

    • acute subdural hematoma

    • no patient consent

    • subdural hygroma

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Neurosurgery, Heinrich-Heine-University Düsseldorf Düsseldorf NRW Germany 40225

    Sponsors and Collaborators

    • Heinrich-Heine University, Duesseldorf

    Investigators

    • Principal Investigator: Kerim Beseoglu, MD, PhD, Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heinrich-Heine University, Duesseldorf
    ClinicalTrials.gov Identifier:
    NCT04170582
    Other Study ID Numbers:
    • 2019-569
    First Posted:
    Nov 20, 2019
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heinrich-Heine University, Duesseldorf
    Hemorrhage
    Subdural
    Chronic Subdural Hematoma
    Chronic
    Additional relevant MeSH terms:
    Hematoma, Subdural
    Hematoma, Subdural, Chronic
    Hematoma

    Study Results

    No Results Posted as of Sep 16, 2021