Effect of prostacyclin infusion on cerebral vessels and metabolism in patients with subarachnoid haemorrhage

INTERVENTION: Trade Name: Flolan Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion Pharmaceutical form of the placebo: Concentrate and diluent for solution for infusion Route of administration of the placebo: Intravenous use CONDITION: Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] Vasospasm following subarachnoid hemorrhage ; MedDRA version: 14.0 Level: LLT Classification code 10042320 Term: Subarachnoid hemorrhage System Organ Class: 10029205 ‐ Nervous system disorders PRIMARY OUTCOME: Main Objective: To evaluate the effect of continues prostacyclin infusion in patient with subarachnoid hemorrhage. Main endpoint is effect on radiographic vasospasm mesured by CT angiography. Primary end point(s): Intra‐arterial diameter i main cerebral arteries measured by CT angiography Secondary Objective: Secondary endpoints is brain metabolism measured by brain microdialysis, clinical vasospasm and biochemical markers. Timepoint(s) of evaluation of this end point: By the end of trial, autumn 2012 SECONDARY OUTCOME: Secondary end point(s): Brain metabolism measured by brain microdialysis ; Clinical vasospasm ; Biochemical markes (markers of endothelial damage) ; Mortality and morbidity ; Timepoint(s) of evaluation of this end point: By the end of trial, autumn 2012 INCLUSION CRITERIA: Subarachnoid hemorrhage Fisher grade 3 + 4 Aneurysm treated Age > 18 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30