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Study on Prognosis of Acutely Ruptured intracranial Aneurysms

Study on Prognosis of Acutely Ruptured intracranial Aneurysms - SPARTA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55176
Enrollment
880
Registered
2019-09-04
Start date
2021-07-14
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain aneurysm stroke

Interventions

None listed

Sponsors

Haaglanden Medisch Centrum (HMC)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The primary outcome is a standardised functional measurement, the score on modified Rankin scale after one year..

Secondary

MeasureTime frame
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

Countries

Netherlands

Contacts

Public ContactWA Moojen

Haaglanden Medisch Centrum (HMC)

w.moojen@haaglandenmc.nl+31(0)88-9792165

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)