Patient Registry for Patients With Chronic Subdural Hematoma

NCT04170582 | Unknown

• 1 other identifier: 2019-569
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Hematoma; Subdural Hematoma; Chronic

Keywords

Hemorrhage; Subdural; Chronic Subdural Hematoma; Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Montreal Cognitive Assessment

  24 month

• Short Form 12 ver. 2

  24 month

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• unilateral or bilateral chronic subdural hematoma
• patient consent

You may not qualify if:

• acute subdural hematoma
• no patient consent
• subdural hygroma

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Department of Neurosurgery, Heinrich-Heine-University Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

MeSH Terms

Conditions

Hematoma; Hematoma, Subdural; Bronchiolitis Obliterans Syndrome; Hemorrhage; Hematoma, Subdural, Chronic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Chronic Disease; Disease Attributes

Study Officials

• Kerim Beseoglu, MD, PhD

  Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerim Beseoglu, MD, PhD

CONTACT

0049-211-81-08333; beseoglu@med.uni-duesseldorf.de

Franziska Staub-Bartelt, MD

CONTACT

0049-211-81-07445; Franziska.Staub-Bartelt@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)