Ignite Creation Date:
2024-05-06 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05132920
Status:
RECRUITING
Last Update Posted:
2023-05-10
First Post:
2021-11-02
Brief Title:
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FINISHER
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-000732-54 | EUDRACT_NUMBER | None | None |