Study on Prognosis of Acutely Ruptured Intracranial Aneurysms

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.

• 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 6 months, 1, 2, 5 and 10 years after onset of symptoms]
• Health associated costs questionnaire [Срок оценки: 3 months, 6 months, 1, 2, 5 and 10 years after onset of symptoms]