FINISHER: Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Sponsor

University Hospital, Bonn (Other)

Overall Status

Recruiting

CT.gov ID

NCT05132920

Collaborator

German Federal Ministry of Education and Research (Other), Pharmacy of the University Hospital Leipzig- AöR (Other), nextevidence GmbH (Other)

334

Enrollment

Locations

Arms

47.9

Anticipated Duration (Months)

27.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage	Drug: Dexamethasone Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Actual Study Start Date :

Dec 3, 2021

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental arm 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	Drug: Dexamethasone 3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21
Placebo Comparator: Control arm 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	Drug: Placebo 3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21

Arm

Intervention/Treatment

Experimental: Experimental arm

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

Drug: Dexamethasone

3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21

Placebo Comparator: Control arm

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

Drug: Placebo

3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21

Outcome Measures

Primary Outcome Measures

modified Rankin Scale (mRS) at 6 months after SAH [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eberhard Karls University of Tübingen	Tübingen	Baden Württemberg	Germany	72076
2	University of Ulm/BKH Günzburg	Günzburg	Bayern	Germany	89312
3	Klinikum rechts der Isar, School of Medicine, Technical University of Munich	München	Bayern	Germany	81675
4	University Medical Center Regensburg	Regensburg	Bayern	Germany	93053
5	Johann Wolfgang Goethe-Universität Frankfurt am Main	Frankfurt	Hessen	Germany	60529
6	University Hospital Bonn	Bonn	NRW	Germany	53127
7	University Hospital of Essen	Essen	NRW	Germany	45147
8	University of Cologne	Köln	NRW	Germany	50937
9	Otto von Guericke University Magdeburg	Magdeburg	Sachsen-Anhalt	Germany	39120
10	University Hospital Leipzig	Leipzig	Sachsen	Germany	04103
11	Charité-Universitätsmedizin Berlin	Berlin		Germany	10117
12	University Medical Center Hamburg-Eppendorf	Hamburg		Germany	20246

Sponsors and Collaborators

University Hospital, Bonn
German Federal Ministry of Education and Research
Pharmacy of the University Hospital Leipzig- AöR
nextevidence GmbH

Investigators

Principal Investigator: Erdem Güresir, Prof. Dr., Department of Neurosurgery, Rheinische Friedrich-Wilhelms-University of Bonn

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erdem Güresir, MD, Prof. Dr. Erdem Güresir, University Hospital, Bonn

ClinicalTrials.gov Identifier:

NCT05132920

Other Study ID Numbers:

NCH-201803
2021-000732-54

First Posted:

Nov 24, 2021

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Subarachnoid Hemorrhage

Inflammation

Hemorrhage

Dexamethasone

Study Results

No Results Posted as of May 19, 2022