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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000732-54 | EudraCT Number |
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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Pharmacy of the University Hospital Leipzig- AöR | UNKNOWN |
| nextevidence GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | 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 |
|
| Control arm | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erdem Güresir, Prof. Dr. | Contact | 0049 - 341 97 17500 | Erdem.Gueresir@medizin.uni-leipzig.de |
| Name | Affiliation | Role |
|---|---|---|
| Erdem Güresir, Prof. Dr. | Department of Neurosurgery, University Hospital Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eberhard Karls University of Tübingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35361026 | Derived | Guresir E, Lampmann T, Bele S, Czabanka M, Czorlich P, Gempt J, Goldbrunner R, Hurth H, Hermann E, Jabbarli R, Krauthausen M, Konig R, Lindner D, Malinova V, Meixensberger J, Mielke D, Nemeth R, Darkwah Oppong M, Pala A, Prinz V, Rashidi A, Roder C, Sandalcioglu IE, Sauvigny T, Schebesch KM, Timmer M, Vajkoczy P, Wessels L, Wild F, Wilhelm C, Wostrack M, Vatter H, Coch C. Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: Study protocol for a randomized controlled trial. Int J Stroke. 2023 Feb;18(2):242-247. doi: 10.1177/17474930221093501. Epub 2022 May 3. |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Placebo | Drug | 3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21 |
|
| University of Ulm/BKH Günzburg | Recruiting | Günzburg | Bavaria | 89312 | Germany |
|
| Klinikum rechts der Isar, School of Medicine, Technical University of Munich | Recruiting | München | Bavaria | 81675 | Germany |
|
| University Medical Center Regensburg | Recruiting | Regensburg | Bavaria | 93053 | Germany |
|
| Johann Wolfgang Goethe-Universität Frankfurt am Main | Recruiting | Frankfurt am Main | Hesse | 60529 | Germany |
|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
|
| University Hospital Bonn | Recruiting | Bonn | North Rhine-Westphalia | 53127 | Germany |
|
| University of Cologne | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
|
| University Hospital of Essen | Recruiting | Essen | North Rhine-Westphalia | 45147 | Germany |
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| University Hospital Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| Otto von Guericke University Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
|
| Charité-Universitätsmedizin Berlin | Recruiting | Berlin | 10117 | Germany |
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| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |