Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHaaglanden Medical Centre

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

880 Participants
are grouped into 2 trial groups
Group A: Neurosurgical treatment
Group B: Endovascular treatment

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year after onset of symptoms

Secondary outcomes

1

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.

Time frame
6 months, 1, 2, 5 and 10 years after onset of symptoms
2

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.

Time frame
6 months, 1, 2, 5 and 10 years after onset of symptoms
3

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.

Time frame
6 months, 1, 2, 5 and 10 years after onset of symptoms
4

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.

Time frame
3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms

Other outcomes

1

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.

Time frame
6 months, 1, 2, 5 and 10 years after onset of symptoms

Sponsors and contacts

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