NCT05851989

Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 880 (estimated)
• Sponsor: Haaglanden Medical Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Rationale: Ruptured intracranial aneurysms resulting in subarachnoid haemorrhage can be treated by open surgical treatment or endovascular treatment. Despite multiple previous studies, biases and uncertainty around the best current treatment practice still exist. The resulting variation of care may result in a variable outcome. The protocol for a prospective multicentre observational study aimed at comparing the effectiveness of different treatment strategies in patients with ruptured aneurysms is presented. Objective: The primary aim of this study is to identify the effectiveness of clipping versus coiling on functional outcome in patients presenting with a subarachnoid haemorrhage due to a ruptured intracranial aneurysm 1 year after onset of symptoms. Secondary objectives include long term functional outcome, complications, cost-effectiveness and explorative analysis of the diagnostic and prognostic value of radiological imaging. Study design: This multi-centre study will have an observational prospective cohort design. Patient will have a follow-up of maximum 10 years. Study population: Patients with a subarachnoid haemorrhage will be included. Patients with evident other causes and patients without diagnosis of intracranial aneurysm after six months will be excluded. Main study parameters/endpoints: The primary endpoint is the score on the modified Rankin scale (mRs) and mortality at 1 year after the initial SAH. Secondary endpoints include the mRs, Modified Telephone Interview of Cognitive Status (TICS-M), 5-level EuroQol-5D (EQ-5D-5L) and derived Quality of Life Years, costs from patient diaries, and the Hospital Anxiety and Depression Scale (HADS), measured at 6 months, 1, 2, 5 and 10 years. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive 'nonexperimental' regular care during their hospital stay. For this study, health questionnaires and functional outcome will be assessed at baseline, follow-up visits and before discharge. Temporary fatigue is the only possible side-effect of completion of the questionnaires.

Conditions

• Aneurysmal Subarachnoid Hemorrhage
• Endovascular Procedures
• Craniotomy
• Patient Outcome Assessment
• Treatment Outcome

Timeline

• Start date: 2021-07-14
• Primary completion: 2025-07-14
• Completion: 2034-07-14
• First posted: 2023-05-10
• Last updated: 2025-03-25

Locations

6 sites across 1 country: Netherlands