Chronic Subdural HematomaNCT06134206
Burr Hole Ultrasound Study
A study testing Trans-burr hole ultrasound in people with Chronic Subdural Hematoma, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality. A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- Trans-burr hole ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2022to 24 Apr 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burr hole surgery due to chronic subdural hematoma
- Routine performance of an computed tomography scan within 3-7 days postoperative
- Ability to give informed consent
Who cannot join
- Performance of prior craniotomy
- Performance of prior revision surgery
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurosurgery, Kepler University Hospital
Linz, Upper Austria, 4020
About this study
Official title: Evaluation of the Feasibility of Measuring Chronic Subdural Hematoma Thickness Via Trans-burrhole Ultrasound
Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality.
A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness sonographically compared to CT.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- Trans-burr hole ultrasound
- Keywords
- Burr hole, Ultrasound, Trans-burr hole, TBUS, Sonography, Chronic Subdural hematoma
- Medical subject headings
- Hematoma, Subdural, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-burr hole ultrasoundDiagnostic test
Also called TBUS, Trans-burr hole sonography, burr hole sonography, burr hole ultrasound
All ultrasound examinations were conducted alongside the routine postoperative CT scan between 3-7 days postoperatively. To minimize potential influences of the patient's head position on the distribution and thickness of the subdural fluid, we first carried out the CT scan with the patient and their head in a supine position. Immediately after the CT scan, the patient remained on the same examination bed, and burr hole ultrasound was performed in the identical supine position. The burr hole was centered in the image, with the outer table surrounding the burr hole displayed as a horizontal line. The content of the burr hole could be differentiated by its higher echogenicity from the subdural residual hematoma or residual fluid. The brain's surface and overlying leptomeninges, however, displayed higher echogenicity compared to the subdural fluid. The subdural hematoma's thickness was measured at its maximum extent.
| Study group | Role | What they receive |
|---|---|---|
| Burr hole sonography | Experimental | Patients within this arm (only arm of the study) undergo burr hole sonography Receives: Diagnostic Test: Trans-burr hole ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
cSDH thickness
maximum extent of the hematoma (chronic subdural hematoma, CSDH) thickness under the burr hole in axial and coronal plane
Measured: 1 measurement on day 3-7 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 May 2022
- Primary completion18 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 1 Group of 20 patients who all underwent the same examination
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harald Stefanits, MD, PhD, Principal investigator, Department of Neurosurgery, Kepler University Hospital Linz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134206
- Sponsor's protocol ID
- EC Nr. 1054/2022
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aspalter S, Gmeiner M, Gasser S, Sonnberger M, Stroh N, Rauch P, Gruber A, Stefanits H. Feasibility, Clinical Potential, and Limitations of Trans-Burr Hole Ultrasound for Postoperative Evaluation of Chronic Subdural Hematoma: A Prospective Pilot Study. Neurosurgery. 2024 Oct 1;95(4):924-931. doi: 10.1227/neu.0000000000002957. Epub 2024 Apr 22.
PubMed 38647289
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Measuring Chronic Subdural Hematoma Thickness Via Trans-burrhole Ultrasound
- ClinicalTrials.gov ID
- NCT06134206
- Acronym / sponsor ID
- EC Nr. 1054/2022
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Burr hole, Ultrasound, Trans-burr hole, TBUS, Sonography, Chronic Subdural hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 18 Nov 2023 (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.
Chronic subdural hematoma (CSDH) is commonly managed through burr hole evacuation. This study evaluates the feasibility of trans burr hole sonography as an alternative postoperative imaging modality.
A pilot study on 20 patients who underwent burr hole surgery for CSDH was therefore planned. Postoperative imaging included both CT and sonographic examinations through the burr hole. We assessed the ability to measure residual subdural fluid thickness sonographically compared to CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 1 Group of 20 patients who all underwent the same examination
| Arm | Type | Receives |
|---|---|---|
| Burr hole sonography | Experimental | Diagnostic Test: Trans-burr hole ultrasoundPatients within this arm (only arm of the study) undergo burr hole sonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Burr hole surgery due to chronic subdural hematoma
- Routine performance of an computed tomography scan within 3-7 days postoperative
- Ability to give informed consent
Key exclusion criteria (2 listed)
- Performance of prior craniotomy
- Performance of prior revision surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-burr hole ultrasoundAlso: TBUS, Trans-burr hole sonography, burr hole sonography, burr hole ultrasoundAll ultrasound examinations were conducted alongside the routine postoperative CT scan between 3-7 days postoperatively. To minimize potential influences of the patient's head position on the distribution and thickness of the subdural fluid, we first carried out the CT scan with the patient and their head in a supine position. Immediately after the CT scan, the patient remained on the same examination bed, and burr hole ultrasound was performed in the identical supine position. The burr hole was centered in the image, with the outer table surrounding the burr hole displayed as a horizontal line. The content of the burr hole could be differentiated by its higher echogenicity from the subdural residual hematoma or residual fluid. The brain's surface and overlying leptomeninges, however, displayed higher echogenicity compared to the subdural fluid. The subdural hematoma's thickness was measured at its maximum extent. | Diagnostic test | Burr hole sonography |
Primary outcome
cSDH thickness
Time frame: 1 measurement on day 3-7 postoperative
maximum extent of the hematoma (chronic subdural hematoma, CSDH) thickness under the burr hole in axial and coronal plane
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 38647289Aspalter S, Gmeiner M, Gasser S, Sonnberger M, Stroh N, Rauch P, Gruber A, Stefanits H. Feasibility, Clinical Potential, and Limitations of Trans-Burr Hole Ultrasound for Postoperative Evaluation of Chronic Subdural Hematoma: A Prospective Pilot Study. Neurosurgery. 2024 Oct 1;95(4):924-931. doi: 10.1227/neu.0000000000002957. Epub 2024 Apr 22.
- 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.
Harald Stefanits, MD, PhD principal investigator
Department of Neurosurgery, Kepler University Hospital Linz, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-burr hole ultrasound in people with Chronic Subdural Hematoma, run by Kepler University Hospital at 1 site in Austria.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Nov 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cSDH thickness (time frame: 1 measurement on day 3-7 postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134206, which also lists 1 linked publication.
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 18 Nov 2023.