Chronic Subdural HematomaCSDH RegistryNCT06759428
Registry of Chronic Subdural Hematoma
An observational study of Chronic Subdural Hematoma and Registry, run by Erasmus Medical Center at 2 sites in Netherlands.
Trial summary
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions: 1. What are the characteristics of patients with CSDH when they are diagnosed? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Registry
- How many people
- 1,500 participants
- Where
- 2 sitesNetherlands
- Study dates
- 1 Oct 2021to Jan 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with CSDH will be recruited from participating centers.
Who may be able to join
- Patients diagnosed with CSDH
- 18 years or older
Who cannot join
- Patients who do not consent to participate in the registry
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dana C. Holl contact
Netherlands2 sites, 2 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Dagmar Verbaan
- Recruiting
Erasmus MC
Rotterdam
Rahman Fakhry
Ruben Dammers
About this study
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:
- What are the characteristics of patients with CSDH when they are diagnosed?
- What treatments do patients with CSDH receive?
- What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?
Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
Read the detailed description
Rationale:
Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential.
Objective:
To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma.
Study design:
A prospective, observational multicenter cohort study.
Study population:
All adult patients diagnosed with chronic subdural hematoma.
Main study parameters/endpoints:
The primary endpoint is functional outcome, measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints, also assessed at 3 months, include recurrence, mortality, complications, hospital length of stay, Markwalder Grading Scale (MGS), modified National Institutes of Health Stroke Scale (mNIHSS), and Telephone Interview for Cognitive Status (TICS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be treated in accordance with standard clinical practice. Study participation imposes minimal additional burden, consisting of a single telephone interview at three months, estimated to take approximately 10 minutes. The findings from this registry are expected to benefit future CSDH patients by informing evidence-based guidelines and improving care practices.
- Conditions
- Chronic Subdural Hematoma, Registry
- Keywords
- Chronic subdural hematoma, Traumatic Brain Injury, Registry, Treatment outcome, Burr hole drainage, modified Rankin Scale
- Medical subject headings
- Hematoma, Subdural, Chronic, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CSDH patients | All adult patients diagnosed with chronic subdural hematoma who provide informed consent to participate in the study will be included. Participants will receive standard care, with treatment determined by their treating physician based on clinical judgment. Treatment options may include burr hole drainage, craniotomy, embolization of the middle meningeal artery, pharmacological management, or a wait-and-scan approach. Follow-up will be conducted at 3 months via a telephone interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS) score at 3 months following diagnosis
Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.
Measured: 3 months following diagnosis
Secondary outcomes (7)
Recurrence rate within 3 months following diagnosis
Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.
Measured: 3 months following diagnosis
Mortality within 3 months following diagnosis
All-cause mortality.
Measured: 3 months following diagnosis
Complications within 3 months following diagnosis
Complications after treatment of CSDH.
Measured: 3 months following diagnosis
Duration of hospital stay
Total number of days admitted to the hospital for CSDH-related causes.
Measured: 3 months following diagnosis
Markwalder Grading Scale (MGS) score at 3 months following diagnosis
Neurological outcome assessed using the Markwalder Grading Scale (MGS), a 4-point scale where 0 indicates no symptoms, higher scores reflect greater neurological disability, and 4 represents coma.
Measured: 3 months following diagnosis
modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis
Neurological outcome assessed using the modified National Institutes of Health Stroke Scale (mNIHSS), a standardized tool ranging from 0 to 31, where 0 indicates no neurological deficits, and higher scores reflect increasing severity of stroke-related impairments.
Measured: 3 months following diagnosis
Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis
Cognitive status assessed using the Telephone Interview for Cognitive Status (TICS), a standardized tool ranging from 0 to 50, where higher scores indicate better cognitive functioning, and lower scores reflect greater cognitive impairment.
Measured: 3 months following diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start1 Oct 2021
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- 1,500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R. Dammers, Erasmus Medical Center
- Investigators
- Ruben Dammers, Principal investigator, Erasmus Medical CenterDagmar Verbaan, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759428
- Sponsor's protocol ID
- MEC-2021-0629
- Acronym
- CSDH Registry
- Status last verified
- Jan 2025
- First submitted
- 29 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified research data may be shared with third parties to enhance its scientific value. Requests for data must be submitted to the principal investigators, accompanied by a detailed description of the study's objectives and methods. Data will be available for sharing beginning in January 2028. Sharing will be permitted for scientific purposes, such as individual patient meta-analyses. Additionally, explicit consent will be required for sharing de-identified data outside the European Union.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Chronic Subdural Hematoma
- ClinicalTrials.gov ID
- NCT06759428
- Acronym / sponsor ID
- CSDH Registry / MEC-2021-0629
- Conditions
- Chronic Subdural Hematoma, Registry
- Keywords
- Chronic subdural hematoma, Traumatic Brain Injury, Registry, Treatment outcome, Burr hole drainage, modified Rankin Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Jan 2025 (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.
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:
- What are the characteristics of patients with CSDH when they are diagnosed?
- What treatments do patients with CSDH receive?
- What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?
Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
Detailed description
Rationale:
Chronic subdural hematoma (CSDH) is a common condition encountered by neurologists and neurosurgeons. While guidelines for the management of CSDH have recently been developed, high-quality evidence to inform these recommendations, particularly level I evidence from randomized clinical trials (RCTs), is awaited. Significant variability in the management of CSDH persists at international, national, and inter-hospital levels. To further refine and implement evidence-based guidelines, a detailed understanding of current clinical practices and their associated outcomes is essential.
Objective:
To describe the baseline characteristics, treatment strategies, and outcomes of patients diagnosed with chronic subdural hematoma.
Study design:
A prospective, observational multicenter cohort study.
Study population:
All adult patients diagnosed with chronic subdural hematoma.
Main study parameters/endpoints:
The primary endpoint is functional outcome, measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints, also assessed at 3 months, include recurrence, mortality, complications, hospital length of stay, Markwalder Grading Scale (MGS), modified National Institutes of Health Stroke Scale (mNIHSS), and Telephone Interview for Cognitive Status (TICS).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Patients will be treated in accordance with standard clinical practice. Study participation imposes minimal additional burden, consisting of a single telephone interview at three months, estimated to take approximately 10 minutes. The findings from this registry are expected to benefit future CSDH patients by informing evidence-based guidelines and improving care practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSDH patients | – | –All adult patients diagnosed with chronic subdural hematoma who provide informed consent to participate in the study will be included. Participants will receive standard care, with treatment determined by their treating physician based on clinical judgment. Treatment options may include burr hole drainage, craniotomy, embolization of the middle meningeal artery, pharmacological management, or a wait-and-scan approach. Follow-up will be conducted at 3 months via a telephone interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with CSDH will be recruited from participating centers.
Key inclusion criteria (2 listed)
- Patients diagnosed with CSDH
- 18 years or older
Key exclusion criteria (1 listed)
- Patients who do not consent to participate in the registry
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
modified Rankin Scale (mRS) score at 3 months following diagnosis
Time frame: 3 months following diagnosis
Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.
7 secondary outcomes
Recurrence rate within 3 months following diagnosis
Time frame: 3 months following diagnosis
Mortality within 3 months following diagnosis
Time frame: 3 months following diagnosis
Complications within 3 months following diagnosis
Time frame: 3 months following diagnosis
Duration of hospital stay
Time frame: 3 months following diagnosis
Markwalder Grading Scale (MGS) score at 3 months following diagnosis
Time frame: 3 months following diagnosis
modified National Institutes of Health Stroke Scale (mNIHSS) score at 3 months following diagnosis
Time frame: 3 months following diagnosis
Telephone Interview for Cognitive Status (TICS) score at 3 months following diagnosis
Time frame: 3 months following diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- This link provides access to the official website of the study, offering a description of the project, including its objectives, methodology, and relevant details.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified research data may be shared with third parties to enhance its scientific value. Requests for data must be submitted to the principal investigators, accompanied by a detailed description of the study's objectives and methods. Data will be available for sharing beginning in January 2028. Sharing will be permitted for scientific purposes, such as individual patient meta-analyses. Additionally, explicit consent will be required for sharing de-identified data outside the European Union.
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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.
Dana C. Holl contact
Ruben Dammers principal investigator
Erasmus Medical Center
Dagmar Verbaan principal investigator
Amsterdam UMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Subdural Hematoma and Registry, run by Erasmus Medical Center at 2 sites in Netherlands.
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 1 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: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahman Fakhry (+31 10 7043507, r.fakhry@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (mRS) score at 3 months following diagnosis (time frame: 3 months following diagnosis). 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 7 Jan 2025.