About this trial
The SPARTA study is a prospective multicenter observational trial in the Netherlands with the aim of identifying the best clinical care in patients with aneurysmal subarachnoidal haemorrhage. Differences in outcome between surgical treatment and endovascular treatment will be explored.
Furthermore, cost effectiveness and radiological prognostic factors will be examined.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of subarachnoid haemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan)
Intracranial aneurysm proven within 6 months to be the cause of subarachnoid haemorrhage
Age 18 years or over at presentation.
Written informed consent
Disqualifiers
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 6 months after onset of symptoms.
Trial population
All patients that present primarily or after acute referral (in-patient to in-patient) to the participating centres, with a spontaneous subarachnoid haemorrhage will be screened for eligibility for this study by the treating physicians or local research nurses.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The score on the modified Rankin Scale at 1 year after onset of symptoms.
Scoring of functional outcome using the modified Rankin Scale. The scale has a minimum value of 0, meaning no symptoms, and a maximum value of 6, meaning dead. The modified Rankin Scale measures the degree of dependence. A higher score means a worse outcome.
Secondary outcomes
modified Rankin Scale at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of case report forms by local treating teams
Scoring of functional outcome using the modified Rankin Scale. The scale has a minimum value of 0, meaning no symptoms, and a maximum value of 6, meaning dead. The modified Rankin Scale measures the degree of dependence. A higher score means a worse outcome.
Modified Telephone Interview for Cognitive Status at 6 months, 1, 2, 5 and 10 years after onset as measured by completion of case report forms by local treating teams
Scoring of cognitive outcome using the Modified Telephone Interview for Cognitive Status. This type of scoring contains multiple elements for detecting anamnestic mild cognitive impairment. The score ranges from 0 to 50, a higher score means a better outcome.
5-level EuroQol-5D questionnaire at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of questionnaires by subjects
Scoring of quality of life using the 5-level EuroQol-5D questionnaire. The questionnaire contains 5 scores in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A higher score means a worse outcome.
Health associated costs questionnaire
Estimation of societal costs by completion of a custom healthcare consumption and loss of productivity (paid and unpaid) questionnaire at 3 months, 6 months, 1 year, 2 years, 5 years and 10 years.
Other outcomes
Recanalization or recurrence of the treated aneurysm.
Degree of occlusion in % of the aneurysm measured on imaging during follow-up using Computed Tomography, Diagnostic Angiography or Magnetic Resonance Imaging. A higher degree of occlusion means a better outcome.
Sponsors and contacts
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