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Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Sponsor: University Hospital, Bonn
Summary
Aneurysmal subarachnoid hemorrhage (SAH) is a fatal disease with high morbidity and mortality. While the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (DCI) during the course of the disease might be a target for intervention in order to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. There are strong indications that inflammation contributes to DCI and therefore poor outcome and plays a major role in SAH. Some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (GC) in SAH patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of GC, so that current guidelines do not recommend the use of GC in SAH so far. This multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (DEX) improves the outcome in a clinically relevant endpoint in SAH patients. Moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of SAH patients defines a subgroup that particularly responds to a treatment with DEX.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
334
Start Date
2021-12-03
Completion Date
2026-09-09
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone
3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21
Placebo
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21
Locations (13)
Eberhard Karls University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
University of Ulm/BKH Günzburg
Günzburg, Bavaria, Germany
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
München, Bavaria, Germany
University Medical Center Regensburg
Regensburg, Bavaria, Germany
Johann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany
Hannover Medical School
Hanover, Lower Saxony, Germany
University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
University of Cologne
Cologne, North Rhine-Westphalia, Germany
University Hospital of Essen
Essen, North Rhine-Westphalia, Germany
University Hospital Leipzig
Leipzig, Saxony, Germany
Otto von Guericke University Magdeburg
Magdeburg, Saxony-Anhalt, Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany