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COMPLETED
NCT05132920
PHASE3

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Sponsor: University Hospital, Bonn

View on ClinicalTrials.gov

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

Interventions

DRUG

Dexamethasone

3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21

DRUG

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