Aneurysmal Subarachnoid Hemorrhage (SAH)
Conditions
Brief summary
Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS) 6 months after the subarachnoid hemorrhage - dichotomized in “favourable (mRS 0-3) versus “unfavourable“ (mRS 4-6) outcome.
Detailed description
a) Analysis of mortality at 7, 90 and 365 days after aSAH b) Comparison of time of death in patients, Length of ICU stay and hospitalization after aSAH, Delayed ischemic neurological deficit (DIND), Symptomatic vasospasm measured by transcranial doppler / computed tomography scans / MR angiography / angiography, Level of inflammation parameters such as CRP, PCT, WBC, IL-6 in serum, Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH, Analysis of AEs by number, severity, relationship
Interventions
DRUGplacebo to match Dexa 8 mg inject JENAPHARM® name of manufacturer: mibe
Sponsors
Rheinische Friedrich-Wilhelms-Universitaet Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of combined mortality and severe disability between study arms, assessed by the modified Rankin Scale (mRS) 6 months after the subarachnoid hemorrhage - dichotomized in “favourable (mRS 0-3) versus “unfavourable“ (mRS 4-6) outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Analysis of mortality at 7, 90 and 365 days after aSAH b) Comparison of time of death in patients, Length of ICU stay and hospitalization after aSAH, Delayed ischemic neurological deficit (DIND), Symptomatic vasospasm measured by transcranial doppler / computed tomography scans / MR angiography / angiography, Level of inflammation parameters such as CRP, PCT, WBC, IL-6 in serum, Analysis of SF36 scores and EQ-ED scores in patients on discharge and at 90, 180 and 365 days after aSAH, Analysis of AEs by number, severity, relationship | — |
Countries
Germany
Outcome results
None listed