Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Who is this study for? Patients with Aneurysmal Subarachnoid Hemorrhage
What treatments are being studied? Dexamethasone
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects, equal or older than 18 years old

• Written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible)

• Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion.

Locations
Other Locations
Germany
Charité-Universitätsmedizin Berlin
RECRUITING
Berlin
University Hospital Bonn
RECRUITING
Bonn
University of Cologne
RECRUITING
Cologne
University Hospital of Essen
RECRUITING
Essen
Johann Wolfgang Goethe-Universität Frankfurt am Main
RECRUITING
Frankfurt Am Main
University of Ulm/BKH Günzburg
RECRUITING
Günzburg
University Medical Center Hamburg-Eppendorf
RECRUITING
Hamburg
Hannover Medical School
RECRUITING
Hanover
University Hospital Leipzig
RECRUITING
Leipzig
Otto von Guericke University Magdeburg
RECRUITING
Magdeburg
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
RECRUITING
München
University Medical Center Regensburg
RECRUITING
Regensburg
Eberhard Karls University of Tübingen
RECRUITING
Tübingen
Contact Information
Primary
Erdem Güresir, Prof. Dr.
Erdem.Gueresir@medizin.uni-leipzig.de
0049 - 341 97 17500
Time Frame
Start Date: 2021-12-03
Estimated Completion Date: 2025-12
Participants
Target number of participants: 334
Treatments
Experimental: Experimental arm
3 x 8 mg (2 ml) dexamethasone daily for days 1-7 and 1 x 8 mg (2 ml) dexamethasone daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients
Placebo_comparator: Control arm
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21 in addition to aneurysm treatment and best medical intensive care of SAH patients
Related Therapeutic Areas
Sponsors
Collaborators: Pharmacy of the University Hospital Leipzig- AöR, German Federal Ministry of Education and Research, nextevidence GmbH
Leads: University Hospital, Bonn

This content was sourced from clinicaltrials.gov

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