SPARTA: Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

Sponsor

Haaglanden Medical Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05851989

Collaborator

(none)

880

Enrollment

Locations

156

Anticipated Duration (Months)

176

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage Endovascular Procedures Craniotomy Patient Outcome Assessment Treatment Outcome

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

Study Type:

Observational

Anticipated Enrollment :

880 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

Actual Study Start Date :

Jul 14, 2021

Anticipated Primary Completion Date :

Jul 14, 2025

Anticipated Study Completion Date :

Jul 14, 2034

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

The score on the modified Rankin Scale at 1 year after onset of symptoms. [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.

Secondary Outcome Measures

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 [6 months, 1, 2, 5 and 10 years 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.
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 [6 months, 1, 2, 5 and 10 years after onset of symptoms]
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.
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 [6 months, 1, 2, 5 and 10 years after onset of symptoms]
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.
Health associated costs questionnaire [3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms]
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.

Other Outcome Measures

Recanalization or recurrence of the treated aneurysm. [6 months, 1, 2, 5 and 10 years after onset of symptoms]
Degree of occlusion in % of the aneurysm measured on imaging during follow-up using Computed Tomography, Diagnostic Angiography or Magnetic Resonance Imaging. A higher degree of occlusion means a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Amsterdam UMC	Amsterdam	Netherlands
2	Haaglanden Medical Center	Den Haag	Netherlands
3	Maastricht UMC	Maastricht	Netherlands
4	Radboudumc	Nijmegen	Netherlands
5	Erasmus MC	Rotterdam	Netherlands