ClinicalTrials.gg
CompletedNCT06134206Updated Nov 18, 2023

Burr Hole Ultrasound Study

An interventional study of Trans-burr hole ultrasound in Chronic Subdural Hematoma, sponsored by Kepler University Hospital. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by Kepler University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled May 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Subdural Hematoma

Keywords

  • Burr hole
  • Ultrasound
  • Trans-burr hole
  • TBUS
  • Sonography
  • Chronic Subdural hematoma
03

In context

Hematoma, Subdural, Chronic

112 studies on the registry are indexed under Hematoma, Subdural, Chronic; 49 are open to participants now.

This study's enrollment of 20 is below the median of 185 across 86 interventional studies indexed under Hematoma, Subdural, Chronic.

Browse Hematoma, Subdural, Chronic studies →

Lead sponsor

Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Burr hole surgery due to chronic subdural hematoma
  • Routine performance of an computed tomography scan within 3-7 days postoperative
  • Ability to give

Exclusion criteria

Exclusion Criteria:

  • Performance of prior craniotomy
  • Performance of prior revision surgery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Burr hole sonography

    Patients within this arm (only arm of the study) undergo burr hole sonography

    Diagnostic Test: Trans-burr hole ultrasound

Interventions

  • Diagnostic testTrans-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.

    Also known as: TBUS, Trans-burr hole sonography, burr hole sonography, burr hole ultrasound

06

What researchers measure

Primary outcomes

  1. cSDH thickness

    maximum extent of the hematoma (chronic subdural hematoma, CSDH) thickness under the burr hole in axial and coronal plane

    Time frame: 1 measurement on day 3-7 postoperative

07

Study locations

1 site
  • Department of Neurosurgery, Kepler University Hospital
    Linz, Upper Austria 4020, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2022 to primary completion in Apr 2023, 11 months.

Of 44 interventional studies with no phase under Hematoma, Subdural, Chronic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's 11 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2023
First posted
Nov 18, 2023
StartActual
May 1, 2022
Primary completionActual
Apr 18, 2023
CompletionActual
Apr 24, 2023
Last update
Nov 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06134206
Lead sponsor
Kepler University Hospital
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
May 1, 2022
Primary completion
Apr 18, 2023
Completion
Apr 24, 2023
Last update
Nov 18, 2023

Study contacts

Harald Stefanits, MD, PhD
principal investigator · Department of Neurosurgery, Kepler University Hospital Linz, Austria

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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