Aneurysmal Subarachnoid HemorrhageSPARTANCT05851989
Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
An observational study of Aneurysmal Subarachnoid Hemorrhage and Endovascular Procedures, run by Haaglanden Medical Centre at 6 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Endovascular Procedures, Craniotomy
- How many people
- 880 participants
- Where
- 6 sitesNetherlands
- Study dates
- 14 Jul 2021to 30 Nov 2036
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that present primarily or after acute referral (in-patient to in-patient) to the participating centres, with a spontaneous subarachnoid haemorrhage will be screened for eligibility for this study by the treating physicians or local research nurses.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Amsterdam UMC
Amsterdam
Maastricht UMC
Maastricht
Radboudumc
Nijmegen
Erasmus MC
Rotterdam
Haaglanden Medical Center
The Hague
Universitair Medisch Centrum Utrecht
Utrecht, Utrecht
About this study
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.
Read the 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
- Keywords
- Aneurysmal subarachnoid hemorrhage, Clipping, Neurosurgery, Coiling, Endovascular treatment, Outcome, Modified Rankin Scale
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurosurgical treatment | This cohort contains the patients with aneurysmal subarachnoid hemorrhage who received the neurosurgical clipping treatment. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score on the modified Rankin Scale at 1 year after onset of symptoms.
Scoring of functional outcome using the modified Rankin Scale. The scale has a minimum value of 0, meaning no symptoms, and a maximum value of 6, meaning dead. The modified Rankin Scale measures the degree of dependence. A higher score means a worse outcome.
Measured: 1 year after onset of symptoms
Secondary outcomes (4)
modified Rankin Scale at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of case report forms by local treating teams
Scoring of functional outcome using the modified Rankin Scale. The scale has a minimum value of 0, meaning no symptoms, and a maximum value of 6, meaning dead. The modified Rankin Scale measures the degree of dependence. A higher score means a worse outcome.
Measured: 6 months, 1, 2, 5 and 10 years after onset of symptoms
Modified Telephone Interview for Cognitive Status at 6 months, 1, 2, 5 and 10 years after onset as measured by completion of case report forms by local treating teams
Scoring of cognitive outcome using the Modified Telephone Interview for Cognitive Status. This type of scoring contains multiple elements for detecting anamnestic mild cognitive impairment. The score ranges from 0 to 50, a higher score means a better outcome.
Measured: 6 months, 1, 2, 5 and 10 years after onset of symptoms
5-level EuroQol-5D questionnaire at 6 months, 1, 2, 5 and 10 years after onset of symptoms, as measured by completion of questionnaires by subjects
Scoring of quality of life using the 5-level EuroQol-5D questionnaire. The questionnaire contains 5 scores in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A higher score means a worse outcome.
Measured: 6 months, 1, 2, 5 and 10 years after onset of symptoms
Health associated costs questionnaire
Estimation of societal costs by completion of a custom healthcare consumption and loss of productivity (paid and unpaid) questionnaire at 3 months, 6 months, 1 year, 2 years, 5 years and 10 years.
Measured: 3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start14 Jul 2021
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haaglanden Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wouter Moojen, Haaglanden Medical Centre
- Investigators
- Wouter Moojen, MD, PhD, Principal investigator, Haaglanden Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851989
- Sponsor's protocol ID
- NL71261.058.19
- Acronym
- SPARTA
- Status last verified
- Oct 2026
- First submitted
- 22 Feb 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38368355