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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
334
3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21
Eberhard Karls University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGUniversity of Ulm/BKH Günzburg
Günzburg, Bavaria, Germany
RECRUITINGKlinikum rechts der Isar, School of Medicine, Technical University of Munich
München, Bavaria, Germany
RECRUITINGUniversity Medical Center Regensburg
Regensburg, Bavaria, Germany
RECRUITINGJohann Wolfgang Goethe-Universität Frankfurt am Main
Frankfurt am Main, Hesse, Germany
RECRUITINGHannover Medical School
Hanover, Lower Saxony, Germany
RECRUITINGUniversity Hospital Bonn
Bonn, North Rhine-Westphalia, Germany
RECRUITINGUniversity of Cologne
Cologne, North Rhine-Westphalia, Germany
RECRUITINGUniversity Hospital of Essen
Essen, North Rhine-Westphalia, Germany
RECRUITINGUniversity Hospital Leipzig
Leipzig, Saxony, Germany
RECRUITING...and 3 more locations
modified Rankin Scale (mRS) at 6 months after SAH
Dichotomized modified Rankin Scale (mRS) 6 months after subarachnoid haemorrhage. The dichotomization will be done in the classes "favourable" (mRS 0-3) versus "unfavourable " (mRS 4-6) outcome.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.