Study on Prognosis of Acutely Ruptured Intracranial Aneurysms (SPARTA)

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysmal Subarachnoid Hemorrhage; Craniotomy; Patient Outcome Assessment; Treatment Outcome; Endovascular Procedures

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 Type: Observational
• Enrollment (Estimated): 880

Contacts and Locations

• Study Contact: Name: Wouter Moojen, MD, PhD; Email: w.moojen@haaglandenmc.nl
• Study Contact Backup: Name: Rick Vreeburg, MD; Phone Number: +31(0)88-9792165; Email: r.j.g.vreeburg@lumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • Amsterdam UMC
    • Contact: Dagmar Verbaan
  • Den Haag, Netherlands
    • Recruiting
    • Haaglanden Medical Center
    • Contact: Rick Vreeburg, MD; Phone Number: +31(0)88-9792165
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht UMC
    • Contact: Roel Haeren
  • Nijmegen, Netherlands
    • Recruiting
    • Radboudumc
    • Contact: Jeroen Boogaarts
  • Rotterdam, Netherlands
    • Recruiting
    • Erasmus MC
    • Contact: Ruben Dammers
  • Utrecht, Netherlands
    • Recruiting
    • Universitair Medisch Centrum Utrecht
    • Contact: Mervyn Vergouwen, PhD; Email: M.D.I.Vergouwen@umcutrecht.nl
    • Contact: Philippine van Wijngaarden, MSc; Email: P.B.vanWijngaarden-5@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haaglanden Medical Centre
• Investigators: Principal Investigator: Wouter Moojen, MD, PhD, Haaglanden Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2021
• Primary Completion (Estimated): July 14, 2025
• Study Completion (Estimated): July 14, 2034

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Outcome; Modified Rankin Scale; Neurosurgery; Endovascular treatment; Coiling; Aneurysmal subarachnoid hemorrhage; Clipping
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Intracranial Arterial Diseases; Intracranial Hemorrhages; Aneurysm; Hemorrhage; Subarachnoid Hemorrhage; Intracranial Aneurysm
• Other Study ID Numbers: NL71261.058.19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No