HematomaCSDH-RNCT04170582
Patient Registry for Patients With Chronic Subdural Hematoma
An observational study of Hematoma and Subdural Hematoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematoma, Subdural Hematoma, Chronic
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2020to Jan 2025
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- unilateral or bilateral chronic subdural hematoma
- patient consent
Who cannot join
- acute subdural hematoma
- no patient consent
- subdural hygroma
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Heinrich-Heine-University Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Kerim Beseoglu, MD, PhD, 0049-211-81 ext. 08333, beseoglu@med.uni-duesseldorf.de
Kerim Beseoglu, MD, PhD
About this study
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).
Read the 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
- Keywords
- Hemorrhage, Subdural, Chronic Subdural Hematoma, Chronic
- Medical subject headings
- Hematoma, Hematoma, Subdural, Bronchiolitis Obliterans Syndrome, Hemorrhage, Hematoma, Subdural, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Month
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start1 Jan 2020
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematomaStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerim Beseoglu, MD, PhD, Principal investigator, Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170582
- Sponsor's protocol ID
- 2019-569
- Acronym
- CSDH-R
- Status last verified
- Mar 2023
- First submitted
- 18 Nov 2019
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Registry for Patients With Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT04170582
- Acronym / sponsor ID
- CSDH-R / 2019-569
- Conditions
- Hematoma, Subdural Hematoma, Chronic
- Keywords
- Hemorrhage, Subdural, Chronic Subdural Hematoma, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 20 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- unilateral or bilateral chronic subdural hematoma
- patient consent
Key exclusion criteria (3 listed)
- acute subdural hematoma
- no patient consent
- subdural hygroma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
National Institut of Health Stroke Scale
Time frame: 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.
2 secondary outcomes
Montreal Cognitive Assessment
Time frame: 24 month
Short Form 12 ver. 2
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerim Beseoglu, MD, PhD principal investigator
Neurosurgery, Heinrich-Heine-University Düsseldorf, Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma and Subdural Hematoma, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerim Beseoglu, MD, PhD (0049-211-81-08333, beseoglu@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institut of Health Stroke Scale (time frame: 24 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.