Clinical trial NCT05851989: Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Official title: Study on Prognosis of Acutely Ruptured Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Haaglanden Medical Centre
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The score on the modified Rankin Scale at 1 year after onset of symptoms.
timeFrame: 1 year after onset of symptoms
Secondary outcomes:
measure: 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
timeFrame: 6 months, 1, 2, 5 and 10 years after onset of symptoms
measure: 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
timeFrame: 6 months, 1, 2, 5 and 10 years after onset of symptoms
measure: 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
timeFrame: 6 months, 1, 2, 5 and 10 years after onset of symptoms
measure: Health associated costs questionnaire
timeFrame: 3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms
Other outcomes:
measure: Recanalization or recurrence of the treated aneurysm.
timeFrame: 6 months, 1, 2, 5 and 10 years after onset of symptoms
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Den Haag
country: Netherlands
facility: Haaglanden Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
Study officials:
affiliation: Haaglanden Medical Center
name: Wouter Moojen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: