Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

NCT05132920 | Unknown Phase 3

• 2 other identifiers: NCH-2018032021-000732-54
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Drug: Dexamethasone

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

Drug: Placebo

Interventions

Dexamethasone DRUG

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

Experimental arm

Placebo DRUG

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

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, equal or older than 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (13)

Eberhard Karls University of Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

University of Ulm/BKH Günzburg

Günzburg, Bavaria, 89312, Germany

RECRUITING

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

München, Bavaria, 81675, Germany

RECRUITING

University Medical Center Regensburg

Regensburg, Bavaria, 93053, Germany

RECRUITING

Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt am Main, Hesse, 60529, Germany

RECRUITING

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

University Hospital of Essen

Essen, North Rhine-Westphalia, 45147, Germany

RECRUITING

University Hospital Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Otto von Guericke University Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 35361026 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Erdem Güresir, Prof. Dr.

  Department of Neurosurgery, University Hospital Leipzig

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erdem Güresir, Prof. Dr.

CONTACT

0049 - 341 97 17500; Erdem.Gueresir@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Erdem Güresir

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 24, 2021
• Study Start: December 3, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

DE (13)