FINISHER - Fight Inflammation to Improve outcome after aneurysmal Subarachnoid Hemorrhage

INTERVENTION: Trade Name: Dexa inject JENAPHARM Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone Other descriptive name: DEXAMETHASONE DIHYDROGEN PHOSPHATE DISODIUM PH. EUR. Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 4‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: aneurysmal subarachnoid hemorrhage ; MedDRA version: 21.1 Level: PT Classification code 10042316 Term: Subarachnoid haemorrhage System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To analyze impact on outcome of an anti‐inflammatory treatment with dexamethasone in patients with acute aneurysmal subarachnoid hem‐orrhage with or without an initial inflammatory sig‐nature in peripheral blood compared to placebo Primary end point(s): Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS) Secondary Objective: 1. Analysis of improvement in survival rate ; 2. Analysis of improvement in recovery time in patients receiving dexamethasonen after aSAH ; 3. Analysis of delayed ischemic neurological deficit (DIND) ; 4. Analysis of symptomatic vasospasm ; 5. Analysis of inflammation parameters ; 6. Evaluation of quality of life (QoL) ; 7. Safety analysis of dexamethasone for treat‐ment in patients suffering from SAH; Timepoint(s) of evaluation of this end point: 6 months after the sub‐arachnoid hemorrhage ‐ dichotomized in “favourable (mRS 0‐3) versus “unfavourable“ (mRS 4‐6) out‐come SECONDARY OUTCOME: Secondary end point(s): Comparison between both treatment arms:; 1. a) Analysis of mortality at 7, 90 and 365 days after a SAH; b) Comparison of time of death in patients; 2. Length of ICU stay and hospitalization after aSAH; 3. Delayed ischemic neurological deficit (DIND); 4. Symptomatic vasospasm measured by transcranial doppler/ computed tomography; scans/ MR angiography/ angiography; 5. Level of inflammation parameters such as CRP, PCT, WBC, IL‐6, IL‐1ß in serum ; 6. Analysis of SF36 scores and EQ‐ED scores in patients on discharge and at 90, 180 and 365 days after aSAH; 7. Analysis of AEs by number, severity, relation‐ship; Timepoint(s) of evaluation of this end point: Analysis of mortality at 7, 90 and 365 days after a SAH; Time of death in patients = upon occurrence; Length of ICU stay and hospitalization after aSAH = upon occurrence; Delayed ischemic neurological deficit (DIND) = upon occurrence; Symptomatic vasospasm measured by tran‐scranial doppler/ computed tomography; scans/ MR angiography/ angiography = Visit 1, 3, 4‐22, 25; Inflammation parameters such as CRP, PCT, WBC, IL‐6, IL‐1ß in serum = Visit 1, 3, 4‐22, 23, 25; SF36 scores and EQ‐ED scores in patients on discharge and at 90, 180 and 365 days after aSAH; AEs by number, severity, relationship = every Visit except for Visit 1 and 26 ; INCLUSION CRITERIA: 1. Male or female subjects, equal or older than 18 years old 2. Written consent to participate in the study by patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the prinicipal investigator is possible) 3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion 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 184 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150