Subarachnoid hemorrhage caused by rupture of cerebral aneurysm MedDRA version: 20.1 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 100000004852
Conditions
Interventions
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Trade Name: sodium chloride
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Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -all patients with a severe SAH (defined by WFNS score = 3, with a aneurysm treated by an arterial embolization; - informed consent of the close (in case of emergency) and of the patients (initially if possible or as soon as possible), -belong to a social security scheme -After a suitable medical examination Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: Traumatic SAH, admission after more than 48 hrs of hemorrhage, neurodegenerative pathology, pregnancy, age < 18 yrs, refusal for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measure of incidence of angiographic vasospasm measured on 15 cerebral arterial segments: basillar vertebro trunk, right and left internal carotid artery, A1, A2, right and left anterior cerebral, M1, M2 of right and left foranity and P1, P2 of the right and left posterior cerebral between J0 and J7. The impact comparison between the two groups will be made. This measurement is performed blindly by an independent radiologist who is not familiar with the treatments received by the patient. ;Secondary Objective: Measure of variation in peak velocity and cerebral blood flow at J0 and J7 Measuring the variation in average transit time (TTM), the infusion scanner on 6 brain regions between J0 and J7. The maximum variation of this parameter will be compared between the two groups. Measuring the incidence of clinical vasospasm in the first 14 days Measuring the number of angiographic dilation or Milrinone dilation procedures required in the first 14 days. Measuring the impact of the J7 recall 3-month prognostic evaluation: Glasgow Outcome Scale (GOS), modified Rankin Scale (mRS), hospital stay in resuscitation and total, hospital and 3-month mortality Systemic hemodynamic J0 and J7 Cerebral hemodynamics, episodes of HTIC (if PIC presents) J0/J7 J0 and J7 entry/exit check.. Blood, urinary and blood gas (GDS) ionogram at J0 and J7 ;Primary end point(s): •Incidence of cerebral vasospasm assessed by cerebral CT-scan angiography and perfusion •Within the first 7 days following arterial embolization of the aneurysm •Lié à la sécurité : 0 OUI 1 NON ;Timepoint(s) of evaluation of this end point: between J0 and J7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Variation of the mean time of cerebral arterial transit on 6 regions of brain, cerebral blood flow and peak of velocity (CT scan with perfusion) - Number of cerebral arterial mechanical (arteriography) and/or pharmacological (milrinone) vasodilation needed within the first 14 days - Incidence of new hemorrhage episodes within the first 7 days - Neurological outcome at 3 months assessed by the Glasgow Outcome Scale (GOS) and the modified Rankin score (mRS) - Secondary Cerebral ischemia at 3 months - Systemic hemodynamic at day 0 and 7 - Numbers of raised intracranial episodes within the first 7 days (in case of intracranial pressure monitoring) - - Plasma and urinary major electrolytes and arterial blood gases at day 0 and 7 ;Timepoint(s) of evaluation of this end point: between J0 and J7 | — |
Countries
France
Contacts
Public Contactmonch
CHU de Nice
Outcome results
None listed