Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— SPARTA  

Official title:

Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851989
• Other study ID #: NL71261.058.19
• Status: Recruiting
• Start date: July 14, 2021
• Est. completion date: July 14, 2034

Study information

• Verified date: February 2023
• Source: Haaglanden Medical Centre
• Contact: Alexander Hamming, MD
• Phone: +31655322609
• Email: a.hamming[@]haaglandenmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Furthermore, cost effectiveness and radiological prognostic factors will be examined.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: July 14, 2034
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysmal Subarachnoid Hemorrhage
• Craniotomy
• Endovascular Procedures
• Hemorrhage
• Intracranial Aneurysm
• Patient Outcome Assessment
• Subarachnoid Hemorrhage
• Treatment Outcome

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Haaglanden Medical Center	Den Haag
Netherlands	Maastricht UMC	Maastricht
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus MC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Haaglanden Medical Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recanalization or recurrence of the treated aneurysm.	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.	6 months, 1, 2, 5 and 10 years after onset of symptoms
Primary	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.	1 year after onset of symptoms
Secondary	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.	6 months, 1, 2, 5 and 10 years after onset of symptoms
Secondary	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.	6 months, 1, 2, 5 and 10 years after onset of symptoms
Secondary	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.	6 months, 1, 2, 5 and 10 years after onset of symptoms
Secondary	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.	3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms