Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
NCT ID: NCT05851989
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
880 participants
OBSERVATIONAL
2021-07-14
2034-07-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Furthermore, cost effectiveness and radiological prognostic factors will be examined.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multidimensional Evaluation of Patients With Ruptured or Unruptured Cerebral Aneurysm Undergoing Endovascular or Surgical Treatment
NCT05713825
International Subarachnoid Aneurysm Trial II
NCT01668563
Flow Diversion in Intracranial Aneurysm Treatment
NCT01349582
Aneurysm Embolization System for Intracranial Aneurysms
NCT06485492
Investigation of the Cerebrospinal Fluid and Further Tissue Samples for Biomarker Indicating Spinal Ischemia and Organ Failure in Patients With Thoracoabdominal Aortic Aneurysm
NCT03093857
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Neurosurgical treatment
This cohort contains the patients with aneurysmal subarachnoid hemorrhage who received the neurosurgical clipping treatment.
No interventions assigned to this group
Endovascular treatment
This cohort contains the patients with neurysmal subarachnoid hemorrhage who received the endovascular coiling treatment. Other endovascular treatments which will be included as well are flow diverter procedures, Woven EndoBridge (WEB) devices and stent assisted coiling.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haaglanden Medical Centre
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wouter Moojen
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wouter Moojen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Haaglanden Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Amsterdam UMC
Amsterdam, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haaglanden Medical Center
The Hague, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dagmar Verbaan
Role: primary
Roel Haeren
Role: primary
Jeroen Boogaarts
Role: primary
Ruben Dammers
Role: primary
Rick Vreeburg, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Hamming AL, van Dijck JTJM, Visser T, Baarse M, Verbaan D, Schenck H, Haeren RHL, Fakhry R, Dammers R, Aquarius R, Boogaarts JHD, Peul WC, Moojen WA. Study on prognosis of acutely ruptured intracranial aneurysms (SPARTA): a protocol for a multicentre prospective cohort study. BMC Neurol. 2024 Feb 17;24(1):68. doi: 10.1186/s12883-024-03567-6.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL71261.058.19
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.