Intrecerebral Haemorrhage
Conditions
Brief summary
The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization
Detailed description
Each individual component of the composite outcome at 24 month after randomization (fatal or non-fatal major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events), Death of any cause at 24 months after randomization, Functional dependence scored on the modified Rankin Scale at 24 months after randomization in a shift analysis, Health-related quality of life measured by the EQ-5D (EuroQoL) at 24 months after randomization, Baseline small-vessel diseases biomarkers on brain MRI (brain microbleeds, leukoaraiosis, superficial siderosis, perivascular spaces, territorial infarcts, silent macrohaemorrhages, cortical atrophy), Complications of endovascular treatment (up to 30 days), Overall evaluation of the success of the procedure (at 30 days)
Interventions
Sponsors
Centre Hospitalier Universitaire De Lille
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite criterion including all fatal or lifethreatening and major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events within 24 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Each individual component of the composite outcome at 24 month after randomization (fatal or non-fatal major vascular events, i.e. cardiovascular/cerebrovascular ischaemic or haemorrhagic intracranial/extracranial events), Death of any cause at 24 months after randomization, Functional dependence scored on the modified Rankin Scale at 24 months after randomization in a shift analysis, Health-related quality of life measured by the EQ-5D (EuroQoL) at 24 months after randomization, Baseline small-vessel diseases biomarkers on brain MRI (brain microbleeds, leukoaraiosis, superficial siderosis, perivascular spaces, territorial infarcts, silent macrohaemorrhages, cortical atrophy), Complications of endovascular treatment (up to 30 days), Overall evaluation of the success of the procedure (at 30 days) | — |
Countries
France
Outcome results
None listed