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Subarachnoid Bleeding Prognosis by Acutely RupTured Aneurysm Study

Subarachnoid Bleeding Prognosis by Acutely RupTured Aneurysm Study - SPARTA

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48437
Enrollment
1500
Registered
2019-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

aneurysma stroke

Interventions

None listed

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Patients with inadequate command of the languages used in the questionnaires (English, Dutch or German).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
-

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)