Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

NCT ID: NCT05132920

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-03
• Study Completion Date: 2025-12-31

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Dexamethasone

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, equal or older than 18 years old

2. 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)

3. Confirmed diagnosis of aneurysmal SAH and onset within 48 hours before inclusion.

Exclusion Criteria

1. SAH due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (AVM), fistula, dissection)

2. 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

3. Patients with obvious evidence of irreparable brainstem or thalamic injury

4. Patients with foreseeable difficulties to attend follow-ups adequately

5. 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

6. Current positive pregnancy test (e.g. β-HCG test in serum)

7. Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure

8. Severe infectious diseases

9. Known angle-closure or open angle glaucoma

10. Known ulceration in the gastro-intestinal tract

11. History of gastro-intestinal bleeding

12. Long-term treatment with corticosteroids prior SAH

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Pharmacy of the University Hospital Leipzig- AöR

UNKNOWN

Sponsor Role: collaborator

nextevidence GmbH

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Erdem Güresir, MD

Prof. Dr. Erdem Güresir

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erdem Güresir, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, University Hospital Leipzig

Locations

Eberhard Karls University of Tübingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

University of Ulm/BKH Günzburg

Günzburg, Bavaria, Germany

Site Status: RECRUITING

Klinikum rechts der Isar, School of Medicine, Technical University of Munich

München, Bavaria, Germany

Site Status: RECRUITING

University Medical Center Regensburg

Regensburg, Bavaria, Germany

Site Status: RECRUITING

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, Germany

Site Status: RECRUITING

Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University of Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Hospital of Essen

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Hospital Leipzig

Leipzig, Saxony, Germany

Site Status: RECRUITING

Otto von Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status: RECRUITING

Charité-Universitätsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Erdem Güresir, Prof. Dr.

Role: CONTACT

Erdem.Gueresir@medizin.uni-leipzig.de

0049 - 341 97 17500

Facility Contacts

Constantin Roder, Prof. Dr.

Role: primary

Helene Hürth, Dr.

Role: backup

Ralph König, Prof. Dr.

Role: primary

Andrej Pala, PD Dr.

Role: backup

Maria Wostrack, PD Dr.

Role: primary

Jens Gempt, Prof. Dr.

Role: backup

Karl-Michael Schebesch, Prof. Dr.

Role: primary

Sylvia Bele, Dr.

Role: backup

Marcus Czabanka, Prof. Dr.

Role: primary

Vincent Prinz, PD Dr.

Role: backup

Florian Wild, Dr.

Role: primary

Elvis Hermann, PD Dr.

Role: backup

Hartmut Vatter, Prof. Dr.

Role: primary

Tim Lampmann

Role: backup

Roland Goldbrunner, Prof. Dr.

Role: primary

Marco Timmer, Dr.

Role: backup

Ramazan Jabbarli, PD Dr.

Role: primary

Marvin Darkhwah Oppong, PD Dr.

Role: backup

Erdem Güresir, Prof. Dr.

Role: primary

Dirk Lindner, PD Dr.

Role: backup

Erol Sandalcioglu, Prof. Dr.

Role: primary

Ali Rashidi, Dr.

Role: backup

Nils Hecht, PD Dr.

Role: primary

Lars Wessels, Dr.

Role: backup

Patrick Czorlich, PD Dr.

Role: primary

Thomas Sauvigny, Dr.

Role: backup

References

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.

Reference Type: DERIVED

PMID: 35361026 (View on PubMed)

Other Identifiers

2021-000732-54

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NCH-201803

Identifier Type: -

Identifier Source: org_study_id