AneurysmNCT05029947
Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms
An observational study of Aneurysm and Aneurysm, Brain, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm, Aneurysm, Brain, Aneurysm Cerebral
- What is being tested?
- Microsurgical Clipping of Unruptured Intracranial Aneurysm
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2016to 31 Dec 2022
- 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: Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
Who may be able to join
- Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
- High-volume centers with ≥40 cases per year during the study period
Who cannot join
- Treatment following subarachnoid haemorrhage
- Clipping following an incomplete occlusion after previous treatment
Trial locations and contacts
1 site in 1 country.
Lasse Dührsen, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Richard Drexler, MD, r.drexler@uke.de
Lasse Dührsen, MD, l.duehrsen@uke.de
About this study
Official title: Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms - An Analysis of Standardized Outcome References From an International Multicentre Cohort
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).
Read the detailed description
Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after microsurgical clipping of unruptured intracranial aneurysms. After successful implementation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.
- Conditions
- Aneurysm, Aneurysm, Brain, Aneurysm Cerebral, Aneurysm of Cerebral Artery, Aneurysm, Intracranial
- Being tested
- Microsurgical Clipping of Unruptured Intracranial Aneurysm
- Medical subject headings
- Aneurysm, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsurgical Clipping of Unruptured Intracranial AneurysmProcedure or surgery
Microsurgical Clipping of Unruptured Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete occlusion of aneurysm
Aneurysm remnant in CT scan or angiography
Measured: up to 6 months
Retreatment of aneurysm
Necessity of retreatment in endovascular or microsurgical technique
Measured: up to 6 months
Mortality
Death of the patient
Measured: up to 6 months
Secondary outcomes (7)
Chronic subdural hematoma
Development of chronic subdural hepatoma requiring intervention
Measured: up to 6 months
Stroke
Occurrence of ischemic stroke
Measured: up to 6 months
Cerebral vasospasm
Occurrence of cerebral vasospasm
Measured: up to 6 months
Intracerebal haemorrhage
Occurrence of intracerebral haemorrhage related to aneurysm treatment
Measured: up to 6 months
New neurological deficit
None, motor deficit, sensory deficit, aphasie
Measured: up to 6 months
Modified Rankin Score
Difference of mRS compared to preoperative status
Measured: up to 6 months
Glasgow Outcome Scale
From 1 (death) to 5 (low disability)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Jan 2016
- Primary completion31 Dec 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Drexler, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Lasse Dührsen, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029947
- Sponsor's protocol ID
- BenchmarkUIA
- Status last verified
- Sep 2022
- First submitted
- 29 Aug 2021
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms - An Analysis of Standardized Outcome References From an International Multicentre Cohort
- ClinicalTrials.gov ID
- NCT05029947
- Acronym / sponsor ID
- BenchmarkUIA
- Conditions
- Aneurysm, Aneurysm, Brain, Aneurysm Cerebral, Aneurysm of Cerebral Artery, Aneurysm, Intracranial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 1 Sep 2021 (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.
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following microsurgical clipping of unruptured intracranial aneurysms (UIA).
Detailed description
Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after microsurgical clipping of unruptured intracranial aneurysms. After successful implementation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
Key inclusion criteria (2 listed)
- Patients who went through elective microsurgical clipping of unruptured intracranial aneurysm
- High-volume centers with ≥40 cases per year during the study period
Key exclusion criteria (2 listed)
- Treatment following subarachnoid haemorrhage
- Clipping following an incomplete occlusion after previous treatment
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 |
|---|---|---|
| Microsurgical Clipping of Unruptured Intracranial AneurysmMicrosurgical Clipping of Unruptured Intracranial Aneurysm | Procedure or surgery | – |
Primary outcome
Complete occlusion of aneurysm
Time frame: up to 6 months
Aneurysm remnant in CT scan or angiography
Retreatment of aneurysm
Time frame: up to 6 months
Necessity of retreatment in endovascular or microsurgical technique
Mortality
Time frame: up to 6 months
Death of the patient
7 secondary outcomes
Chronic subdural hematoma
Time frame: up to 6 months
Stroke
Time frame: up to 6 months
Cerebral vasospasm
Time frame: up to 6 months
Intracerebal haemorrhage
Time frame: up to 6 months
New neurological deficit
Time frame: up to 6 months
Modified Rankin Score
Time frame: up to 6 months
Glasgow Outcome Scale
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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.
Lasse Dührsen, MD contact
Lasse Dührsen, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 Aneurysm and Aneurysm, Brain, run by Universitätsklinikum Hamburg-Eppendorf 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 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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 Richard Drexler, MD (004915222816461, r.drexler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete occlusion of aneurysm (time frame: up to 6 months). The study lists 3 primary outcomes in all. 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 22 Sep 2022.