Objective: The aim of this comparative study is to identify the highest value-based practice for ruptured intracranial aneurysm patients in the short-, medium-, and long term by prospective registration.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Disease specific patient reported outcome,
functional outcome and surgical outcome 1, 2, 5 and 10 years after treatment.
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will receive normal care during their
hospital stay. For study purposes, health questionnaires and functional outcome
will be assessed at baseline and before discharge. During follow-up, patients
will be asked to complete several questionnaires and tests and they will
receive follow-up imaging to assess treatment success. These tests,
questionnaires and imaging will take approximately 2 hours to complete. In
order to improve comparability between centers, we will use a uniform protocol
during follow-up. Some patients will be followed more regularly in this
protocol as compared to their local guidelines. However, we think this does not
attribute to significant risk for our study subjects. Extended follow-up could
even address potential health problems that would have gone unnoticed
previously. We argue that the additional risk of additional imaging with
contrast (preferably and most often done by MRI) does not attribute to a
significant health risk for patients.
Measurements will be done in the hospital, the rehabilitation center,
or in the patient*s home. Patients could become tired after a measurement
moment or follow-up visit, but this tiredness will not last. Also, patients may
be confronted with their morbidity by functional tests. The data acquired in
this study will be used to identify the optimal and most cost-effective
treatment strategy for intracranial aneurysm patients. This will benefit future
intracranial aneurysm patients.
Secondary outcome
-
Background summary
Rationale: Ruptured brain aneurysms can be treated by open surgical treatment
or endovascular treatment. Which treatment has the highest value-based practice
remains unclear since most previous research is biased by selection. We
therefore will perform a comparative effectiveness study.
Study objective
Objective: The aim of this comparative study is to identify the highest
value-based practice for ruptured intracranial aneurysm patients in the short-,
medium-, and long term by prospective registration.
Study design
Study design: This study will have a multi-center prospective cohort design
with clinical data-registration. Patients will be included when they present
with a ruptured intracranial aneurysm and will have a follow-up of 10 years.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Patients will receive normal care during their
hospital stay. For study purposes, health questionnaires and functional outcome
will be assessed at baseline and before discharge. During follow-up, patients
will be asked to complete several questionnaires and tests and they will
receive follow-up imaging to assess treatment success. These tests,
questionnaires and imaging will take approximately 2 hours to complete. In
order to improve comparability between centers, we will use a uniform protocol
during follow-up. Some patients will be followed more regularly in this
protocol as compared to their local guidelines. However, we think this does not
attribute to significant risk for our study subjects. Extended follow-up could
even address potential health problems that would have gone unnoticed
previously. We argue that the additional risk of additional imaging with
contrast (preferably and most often done by MRI) does not attribute to a
significant health risk for patients.
Measurements will be done in the hospital, the rehabilitation center,
or in the patient*s home. Patients could become tired after a measurement
moment or follow-up visit, but this tiredness will not last. Also, patients may
be confronted with their morbidity by functional tests. The data acquired in
this study will be used to identify the optimal and most cost-effective
treatment strategy for intracranial aneurysm patients. This will benefit future
intracranial aneurysm patients.
Lijnbaan 32 Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32 Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
- Patients with a diagnosis of a ruptured intracranial aneurysm on arterial angiogram or CTA.
- Patients with an age over 18 years at presentation.
Exclusion criteria
- Patients with inadequate command of the languages used in the questionnaires (English, Dutch or German).
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL68178.098.19 |