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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT05851989
- Acronym / sponsor ID
- SPARTA / NL71261.058.19
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Haaglanden Medical CentreUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2036 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The score on the modified Rankin Scale at 1 year after onset of symptoms.
Time frame: 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.
4 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 6 months, 1, 2, 5 and 10 years after onset of symptoms
Health associated costs questionnaire
Time frame: 3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 38368355Hamming 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wouter Moojen, MD, PhD principal investigator
Haaglanden Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage and Endovascular Procedures, run by Haaglanden Medical Centre at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score on the modified Rankin Scale at 1 year after onset of symptoms. (time frame: 1 year after onset of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05851989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.