| Title: |
Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial: study protocol for a randomized controlled trial |
| Authors: |
Güresir, Erdem; Lampmann, Tim; Bele, Sylvia; Czabanka, Marcus; Czorlich, Patrick; Gempt, Jens; Goldbrunner, Roland; Hurth, Helene; Hermann, Elvis; Jabbarli, Ramazan; Coch, Christoph |
| Contributors: |
Güresir, Erdem; Lampmann, Tim; Bele, Sylvia; Czabanka, Marcus; Czorlich, Patrick; Gempt, Jens; Goldbrunner, Roland; Hurth, Helene; Hermann, Elvis; Jabbarli, Ramazan; Coch, Christoph |
| Publication Year: |
2022 |
| Collection: |
Georg-August-Universität Göttingen: GoeScholar |
| Description: |
Rationale: Aneurysmal subarachnoid hemorrhage (SAH) has high morbidity and mortality. While the primary injury results from the initial bleeding and cannot currently be influenced, secondary injury through vasospasm and delayed cerebral ischemia worsens outcome and might be a target for interventions to improve outcome. To date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no therapy available, so novel treatment concepts are needed. Evidence suggests inflammation contributes to delayed cerebral ischemia and poor out-come in SAH. Some studies suggest a beneficial effect of anti-inflammatory glucocorticoids, but there are no data from randomized controlled trials examining the efficacy of glucocorticoids. Therefore, current guidelines do not recommend the use of glucocorticoids in SAH. Aim: The Fight INflammation to Improve outcome after aneurysmal Subarachnoid HEmorRhage (FINISHER) trial aims to determine whether dexamethasone improves outcome in a clinically rele-vant endpoint in SAH patients. Methods and design: FINISHER is a multicentre, prospective, randomized, double-blinded, place-bo-controlled clinical phase III trial which is testing the outcome and safety of anti-inflammatory treatment with dexamethasone in SAH patients. Sample size estimates: 334 patients will be randomized to either dexamethasone or placebo within 48h after SAH. The dexamethasone dose is 8mg tds days 1-7 and then 8mg od for days 8-21 Study outcome: The primary outcome is the modified Rankin Scale (mRS) at 6 months which is dichotomized to favourable (mRS 0-3) versus unfavourable (mRS 4-6). Discussion: The results of this study will provide the first phase III evidence as to whether dexame-thasone improves outcome in SAH. Trial registration: ClinicalTrials.gov NCT05132920. EudraCT Number 2021-000732-54. ; Rationale: Aneurysmal subarachnoid hemorrhage (SAH) has high morbidity and mortality. While the primary injury results from the initial bleeding and cannot currently be ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1177/17474930221093501 |
| Availability: |
https://resolver.sub.uni-goettingen.de/purl?gro-2/107371; https://doi.org/10.1177/17474930221093501 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://journals.sagepub.com/page/policies/text-and-data-mining-license |
| Accession Number: |
edsbas.F305F634 |
| Database: |
BASE |