Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

NCT05851989 | Recruiting DMC

• 1 other identifier: NL71261.058.19
• Study Type: observational
• Target: 880
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 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

  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

  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

  6 months, 1, 2, 5 and 10 years after onset of symptoms

• Health associated costs questionnaire

  3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms

Other Outcomes (1)

• Recanalization or recurrence of the treated aneurysm.

  6 months, 1, 2, 5 and 10 years after onset of symptoms

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haaglanden Medical Centre: lead

Study Sites (6)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Maastricht UMC

Maastricht, Netherlands

RECRUITING

Radboudumc

Nijmegen, Netherlands

RECRUITING

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Haaglanden Medical Center

The Hague, Netherlands

RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 38368355 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wouter Moojen, MD, PhD

  Haaglanden Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rick Vreeburg, MD

CONTACT

+31(0)88-9792165; r.j.g.vreeburg@lumc.nl

Wouter Moojen, MD, PhD

CONTACT

w.moojen@haaglandenmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 10, 2023
• Study Start: July 14, 2021
• Primary Completion: July 14, 2025
• Study Completion (Estimated): July 14, 2034
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

NL (6)