Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Status:
Not yet recruiting
Trial end date:
2025-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Bonn
Collaborators:
German Federal Ministry of Education and Research nextevidence GmbH Pharmacy of the University Hospital Leipzig- AöR