Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage (FINISHER)

May 8, 2023 updated by: Erdem Güresir, MD, University Hospital, Bonn

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

334

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charite-Universitatsmedizin Berlin
        • Contact:
          • Nils Hecht, PD Dr.
        • Contact:
          • Lars Wessels, Dr.
      • Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
          • Patrick Czorlich, PD Dr.
        • Contact:
          • Thomas Sauvigny, Dr.
    • Baden Württemberg
      • Tübingen, Baden Württemberg, Germany, 72076
        • Recruiting
        • Eberhard Karls University of Tübingen
        • Contact:
          • Constantin Roder, Prof. Dr.
        • Contact:
          • Helene Hürth, Dr.
    • Bayern
      • Günzburg, Bayern, Germany, 89312
        • Recruiting
        • University of Ulm/BKH Günzburg
        • Contact:
          • Ralph König, Prof. Dr.
        • Contact:
          • Andrej Pala, PD Dr.
      • München, Bayern, Germany, 81675
        • Recruiting
        • Klinikum rechts der Isar, School of Medicine, Technical University of Munich
        • Contact:
          • Maria Wostrack, PD Dr.
        • Contact:
          • Jens Gempt, Prof. Dr.
      • Regensburg, Bayern, Germany, 93053
        • Recruiting
        • University Medical Center Regensburg
        • Contact:
          • Karl-Michael Schebesch, Prof. Dr.
        • Contact:
          • Sylvia Bele, Dr.
    • Hessen
      • Frankfurt, Hessen, Germany, 60529
        • Recruiting
        • Johann Wolfgang Goethe-Universität Frankfurt am Main
        • Contact:
          • Marcus Czabanka, Prof. Dr.
        • Contact:
          • Vincent Prinz, PD Dr.
    • NRW
      • Bonn, NRW, Germany, 53127
        • Recruiting
        • University Hospital Bonn
        • Contact:
          • Hartmut Vatter, Prof. Dr.
        • Contact:
          • Tim Lampmann
      • Essen, NRW, Germany, 45147
        • Recruiting
        • University Hospital of Essen
        • Contact:
          • Ramazan Jabbarli, PD Dr.
        • Contact:
          • Marvin Darkhwah Oppong, PD Dr.
      • Köln, NRW, Germany, 50937
        • Recruiting
        • University of Cologne
        • Contact:
          • Roland Goldbrunner, Prof. Dr.
        • Contact:
          • Marco Timmer, Dr.
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Recruiting
        • Hannover Medical School
        • Contact:
          • Florian Wild, Dr.
        • Contact:
          • Elvis Hermann, PD Dr.
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • University Hospital Leipzig
        • Contact:
          • Erdem Güresir, Prof. Dr.
        • Contact:
          • Dirk Lindner, PD Dr.
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Recruiting
        • Otto von Guericke University Magdeburg
        • Contact:
          • Erol Sandalcioglu, Prof. Dr.
        • Contact:
          • Ali Rashidi, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Rankin Scale (mRS) at 6 months after SAH
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bonn

Collaborators

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, University Hospital Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCH-201803
  • 2021-000732-54 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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