subarachnoid hemorrhage
Conditions
Brief summary
Excellent functional prognosis defined by a score of 0 or 1 on the modified Rankin Scale (mRS) at 6 months. Assessment will be centralised and carried out by telephone by a certified professional, blinded to the randomisation arm.
Detailed description
Focal neurological deficit or decrease in Glasgow score (at least 2 points for at least 1 hour), not immediately after aneurysmal occlusion and not entirely related to another cause (verified by clinical, biological and radiological means), according to the SAHIT (Subarachnoid Hemorrhage International Trialists) definition., Modified Rankin Scale (mRS) score at 6 months, Ischaemic lesions on MRI at D21 post-HSA (or at discharge if before D21). MRI scans will be analysed centrally by a radiologist blinded to the randomisation arm., Treatment of vasospasm defined by one of the following interventions: endovascular treatment or IV infusion of milrinone or increase in blood pressure by vasopressor drugs., Number of days among the 21 days post-HSA (or discharge from hospital if before D21) with prescription of one or more of the treatments mentioned in criterion 4, MoCA-5min score at 6 months, All-cause mortality at D21 (or at hospital discharge if before D21), Serious adverse event, Change in NETs blood concentration between sampling at inclusion and sampling at D21 (or at discharge if before D21).
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Excellent functional prognosis defined by a score of 0 or 1 on the modified Rankin Scale (mRS) at 6 months. Assessment will be centralised and carried out by telephone by a certified professional, blinded to the randomisation arm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Focal neurological deficit or decrease in Glasgow score (at least 2 points for at least 1 hour), not immediately after aneurysmal occlusion and not entirely related to another cause (verified by clinical, biological and radiological means), according to the SAHIT (Subarachnoid Hemorrhage International Trialists) definition., Modified Rankin Scale (mRS) score at 6 months, Ischaemic lesions on MRI at D21 post-HSA (or at discharge if before D21). MRI scans will be analysed centrally by a radiologist blinded to the randomisation arm., Treatment of vasospasm defined by one of the following interventions: endovascular treatment or IV infusion of milrinone or increase in blood pressure by vasopressor drugs., Number of days among the 21 days post-HSA (or discharge from hospital if before D21) with prescription of one or more of the treatments mentioned in criterion 4, MoCA-5min score at 6 months, All-cause mortality at D21 (or at hospital discharge if before D21), Serious adverse event, Change | — |
Countries
France