The goal of this study is to investigate which treatment(-s) lead to the best outcome by using existing variation of practice.
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
The primary outcome is a standardised functional measurement, the score on
modified Rankin scale after one year..
Secondary outcome
Standardised functional outcome measurements:
- modified Rankin scale after six months, two years, five years and ten years
- extended Glasgow Outcome Scale after six months, one year, two years, five
years and ten years
Standardised cognitive status and mood/fatigue measurement:
- Montreal Cognitive Assessment after six months, one year, two years, five
years and ten years
- Rancho los Amigos Levels of Cognitive Functioning Scale after six months, one
year, two years, five years and ten years
- Short form of the multidimensional Fatigue Syptom Inventory after six months,
one year, two years, five years and ten years
- Hospital Anxiety and Depression Scale after six months, one year, two years,
five years and ten years
Standardised measurement of quality of life and reporting of cost-effectivity:
- EQ-5D and visual analogue scale after six months, one year, two years, five
years and ten years
- 36-question short form questionnaire after six months, one year, two years,
five years and ten years
- Quality Adjusted Life years and cost-utility analysis with patient reported
costs through patient diaries
Relation of complications of subarachnoid haemorrhages and their treatment with
the outcomes above:
- hydrocephalus and drainage of cerebrospinal fluid
- delayed cerebral ischemia and its treatment
- rebleeding and its treatment
- recanalisation and its treatment
Role of:
- mobilisation and early rehabilitation in the hospital with the outcomes above
- regional organisation of care, amongst others the referral area, with the
outcomes above
Prediction of outcomes above and occurrence of complications with clinical and
radiological data from presenation
Background summary
Most subarachnoid haemorrhages are caused by a rupture of an intracranial
aneurysm. They have a significant impact on the quality of life of patients and
even their survival. The aneurysm itself can be treated through an open
microsurgical procedure or through an endovascular procedure. Variation still
exists in the treatment, despite previous studies. Knowledge about long term
outcome is scarce, especially about functional and cognitive outcome. Not much
is known about cost-effectivity of the different treatment modalities,
especially on long-term follow-up.
Study objective
The goal of this study is to investigate which treatment(-s) lead to the best
outcome by using existing variation of practice.
Study design
An observational prospective cohort study in multiple hospitals in the
Netherlands will be performed. Patients will be included on presentation with a
subarachnoid haemorrhage and will receive regular therapy as indicated by local
guidelines. There will be no outside influence on this treatment.
Study burden and risks
Patients will receive normal care during their hospital stay and after. There
will be no invasive measurements or experimental treatments for this study.
Patients will be asked to complete questionnaires during their hospital stay
and afterwards during follow-up consultations. They will be asked to answer
questions. Some additional questions will be asked during the follow-up
consultation to complete standardised measurememnt and a physical examination
will take place. The completion of the questionnaires can cause temporary
fatigue and takes time. If patients have difficulty completing the
questionnaires themselves, their representative can help.
Lijnbaan 32
Den Haag 2512 VA
NL
Lijnbaan 32
Den Haag 2512 VA
NL
Listed location countries
Age
Inclusion criteria
- Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture
(in the presence of a negative CT-scan)
- Age eighteen years or over at presentation.
Exclusion criteria
- Subarachnoid haemorrhage deemed most likely of *perimesencephalic* origin
after consideration of history, clinical examination and radiological findings
(including angiographic imaging)
- Subarachnoid haemorrhage deemed most likely of post-traumatic origin after
consideration of history, clinical examination and radiological findings
(including angiographic imaging)
- Diagnosis of intracerebral arteriovenous malformations or dural arteriovenous
fistula.
- No diagnosis of intracranial aneurysm at six months after onset of symptoms.
- Not mastering the Dutch language
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL71261.058.19 |