Patient Registry for Patients With Chronic Subdural Hematoma (CSDH-R)

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).

Study Overview

• Status: Recruiting
• Conditions: Hematoma; Chronic; Subdural Hematoma

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Kerim Beseoglu, MD, PhD; Phone Number: 0049-211-81-08333; Email: beseoglu@med.uni-duesseldorf.de
• Study Contact Backup: Name: Franziska Staub-Bartelt, MD; Phone Number: 0049-211-81-07445; Email: Franziska.Staub-Bartelt@med.uni-duesseldorf.de

Study Locations

• Germany
  • NRW
    • Düsseldorf, NRW, Germany, 40225
      • Recruiting
      • Department of Neurosurgery, Heinrich-Heine-University Düsseldorf
      • Contact: Kerim Beseoglu, MD, PhD; Phone Number: 08333 0049-211-81; Email: beseoglu@med.uni-duesseldorf.de
      • Principal Investigator: Kerim Beseoglu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• unilateral or bilateral chronic subdural hematoma
• patient consent

Exclusion Criteria:

• acute subdural hematoma
• no patient consent
• subdural hygroma

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Hemorrhage; Chronic; Chronic Subdural Hematoma; Subdural
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Hematoma; Hematoma, Subdural; Hematoma, Subdural, Chronic
• Other Study ID Numbers: 2019-569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No