Back to resultsFight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage (FINISHER)
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Recruiting
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dexamethasone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)
- Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study
- Patients with obvious evidence of irreparable brainstem or thalamic injury
- Patients with foreseeable difficulties to attend follow-ups adequately
- Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
- Current positive pregnancy test (e.g. β-HCG test in serum)
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
- Severe infectious diseases
- Known angle-closure or open angle glaucoma
- Known ulceration in the gastro-intestinal tract
- History of gastro-intestinal bleeding
- Long-term treatment with corticosteroids prior SAH
Sites / Locations
- Eberhard Karls University of TübingenRecruiting
- University of Ulm/BKH GünzburgRecruiting
- Klinikum rechts der Isar, School of Medicine, Technical University of MunichRecruiting
- University Medical Center RegensburgRecruiting
- Johann Wolfgang Goethe-Universität Frankfurt am MainRecruiting
- Hannover Medical SchoolRecruiting
- University Hospital BonnRecruiting
- University Hospital of EssenRecruiting
- University of CologneRecruiting
- Otto von Guericke University MagdeburgRecruiting
- University Hospital LeipzigRecruiting
- Charité-Universitätsmedizin BerlinRecruiting
- University Medical Center Hamburg-EppendorfRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental arm
Control arm
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05132920
First Posted
November 2, 2021
Last Updated
May 8, 2023
Sponsor
University Hospital, Bonn
Collaborators
German Federal Ministry of Education and Research, Pharmacy of the University Hospital Leipzig- AöR, nextevidence GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05132920
Brief Title
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Acronym
FINISHER
Official Title
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Bonn
Collaborators
German Federal Ministry of Education and Research, Pharmacy of the University Hospital Leipzig- AöR, nextevidence GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
334 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21
Primary Outcome Measure Information:
Title
modified Rankin Scale (mRS) at 6 months after SAH
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)
Any condition that, in the judgement of the Investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study
Patients with obvious evidence of irreparable brainstem or thalamic injury
Patients with foreseeable difficulties to attend follow-ups adequately
Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
Current positive pregnancy test (e.g. β-HCG test in serum)
Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure
Severe infectious diseases
Known angle-closure or open angle glaucoma
Known ulceration in the gastro-intestinal tract
History of gastro-intestinal bleeding
Long-term treatment with corticosteroids prior SAH
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erdem Güresir, Prof. Dr.
Phone
0049 - 341 97 17500
Email
Erdem.Gueresir@medizin.uni-leipzig.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erdem Güresir, Prof. Dr.
Organizational Affiliation
Department of Neurosurgery, University Hospital Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eberhard Karls University of Tübingen
City
Tübingen
State/Province
Baden Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantin Roder, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Helene Hürth, Dr.
Facility Name
University of Ulm/BKH Günzburg
City
Günzburg
State/Province
Bayern
ZIP/Postal Code
89312
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralph König, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Andrej Pala, PD Dr.
Facility Name
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Wostrack, PD Dr.
First Name & Middle Initial & Last Name & Degree
Jens Gempt, Prof. Dr.
Facility Name
University Medical Center Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl-Michael Schebesch, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Sylvia Bele, Dr.
Facility Name
Johann Wolfgang Goethe-Universität Frankfurt am Main
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60529
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcus Czabanka, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Vincent Prinz, PD Dr.
Facility Name
Hannover Medical School
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Wild, Dr.
First Name & Middle Initial & Last Name & Degree
Elvis Hermann, PD Dr.
Facility Name
University Hospital Bonn
City
Bonn
State/Province
NRW
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hartmut Vatter, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Tim Lampmann
Facility Name
University Hospital of Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramazan Jabbarli, PD Dr.
First Name & Middle Initial & Last Name & Degree
Marvin Darkhwah Oppong, PD Dr.
Facility Name
University of Cologne
City
Köln
State/Province
NRW
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland Goldbrunner, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Marco Timmer, Dr.
Facility Name
Otto von Guericke University Magdeburg
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erol Sandalcioglu, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Ali Rashidi, Dr.
Facility Name
University Hospital Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erdem Güresir, Prof. Dr.
First Name & Middle Initial & Last Name & Degree
Dirk Lindner, PD Dr.
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Hecht, PD Dr.
First Name & Middle Initial & Last Name & Degree
Lars Wessels, Dr.
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Czorlich, PD Dr.
First Name & Middle Initial & Last Name & Degree
Thomas Sauvigny, Dr.
12. IPD Sharing Statement
Learn more about this trial
Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage
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