Prognosis of acutely ruptured intracranial aneurysms
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Haaglanden Medical Centre · NCT05851989
This study is testing whether surgical clipping or endovascular coiling is better for helping patients recover after a brain aneurysm rupture.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 880 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Haaglanden Medical Centre (other) |
| Locations | 6 sites (Amsterdam and 5 other locations) |
| Trial ID | NCT05851989 on ClinicalTrials.gov |
What this trial studies
The SPARTA study is a prospective multicenter observational trial conducted in the Netherlands aimed at identifying the best clinical care for patients with aneurysmal subarachnoid hemorrhage. It will compare the effectiveness of surgical clipping versus endovascular coiling treatments on patient outcomes one year after the onset of symptoms. Additionally, the study will evaluate long-term functional outcomes, complications, cost-effectiveness, and the prognostic value of radiological imaging. Patients will be followed for up to 10 years to gather comprehensive data on their recovery and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over who have a confirmed diagnosis of subarachnoid hemorrhage due to an intracranial aneurysm.
Not a fit: Patients with subarachnoid hemorrhage of perimesencephalic or post-traumatic origin, or those without a diagnosed intracranial aneurysm after six months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with ruptured intracranial aneurysms, potentially improving patient outcomes.
How similar studies have performed: Previous studies have explored treatment options for ruptured intracranial aneurysms, but this study aims to provide more definitive comparisons and insights, making it a valuable addition to existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 6 months after onset of symptoms. * Not mastering the Dutch language
Where this trial is running
Amsterdam and 5 other locations
- Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)
- Maastricht UMC — Maastricht, Netherlands (RECRUITING)
- Radboudumc — Nijmegen, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, Netherlands (RECRUITING)
- Haaglanden Medical Center — The Hague, Netherlands (RECRUITING)
- Universitair Medisch Centrum Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Wouter Moojen, MD, PhD — Haaglanden Medical Center
- Study coordinator: Rick Vreeburg, MD
- Email: r.j.g.vreeburg@lumc.nl
- Phone: +31(0)88-9792165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures, Craniotomy, Patient Outcome Assessment, Treatment Outcome, Aneurysmal subarachnoid hemorrhage, Clipping, Neurosurgery