Study on prognosis of acutely ruptured intracranial aneurysms (SPARTA): a protocol for a multicentre prospective cohort study.
Alexander L Hamming, Jeroen T J M van Dijck, Tjitske Visser...
https://pubmed.ncbi.nlm.nih.gov/38368355Actively Recruiting
Age: 18Years +
All Genders
ID05851989
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Led by Haaglanden Medical Centre · Updated on 2025-03-25
880
Participants Needed
6
Research Sites
469 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best clinical care for patients with aneurysmal subarachnoid hemorrhage, a condition caused by ruptured intracranial aneurysms. This observational study compares surgical clipping and endovascular coiling treatments to understand their effects on patient outcomes. It also examines cost-effectiveness and radiological factors that might predict recovery. Patients receive standard care during hospitalization, either through neurosurgical clipping or various endovascular techniques such as coiling and device-assisted procedures. The study follows patients for up to 10 years, monitoring long-term outcomes and complications. Treatment choices are observed rather than assigned by the study. Participants will complete health questionnaires and functional assessments at several points: baseline, before discharge, and at 6 months, 1, 2, 5, and 10 years after symptom onset. Measures include the modified Rankin Scale for disability, cognitive status interviews, quality of life surveys, and cost diaries. Researchers will track mortality and other health indicators to evaluate treatment effectiveness and patient well-being over time.
CONDITIONS
Brief Title
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of subarachnoid haemorrhage by CT-scan or lumbar puncture
- Intracranial aneurysm proven within 6 months as cause of subarachnoid haemorrhage
- Age 18 years or older at presentation
- Written informed consent provided
You will not qualify if you...
- Subarachnoid haemorrhage likely from perimesencephalic origin based on clinical and imaging evaluation
- Subarachnoid haemorrhage likely from post-traumatic origin based on clinical and imaging evaluation
- Diagnosis of intracerebral arteriovenous malformations or dural arteriovenous fistula
- No diagnosis of intracranial aneurysm at 6 months after symptom onset
- Inability to understand or speak Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 6 months after symptom onset
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for diagnosis confirmation
Monitoring
Duration - Up to 10 years
Participants who undergo routine care for ruptured intracranial aneurysms are observed for outcomes and complications after treatment.
Assessments at 3 months, 6 months, 1, 2, 5, and 10 years after symptom onset
Trial Site Locations
Total: 6 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
2
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
3
Radboudumc
Nijmegen, Netherlands
Actively Recruiting
4
Erasmus MC
Rotterdam, Netherlands
Actively Recruiting
5
Haaglanden Medical Center
The Hague, Netherlands
Actively Recruiting
6
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Actively Recruiting
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Research Team
R
Rick Vreeburg, MD
W
Wouter Moojen, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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