Study on Prognosis of Acutely Ruptured Intracranial Aneurysms (SPARTA)

Haaglanden Medical Centre

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT05851989

NL71261.058.19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

880 participants in 2 patient groups

Neurosurgical treatment

Description:

This cohort contains the patients with aneurysmal subarachnoid hemorrhage who received the neurosurgical clipping treatment.

Endovascular treatment

Description:

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.