CClinicalTrials.gg
RecruitingNCT05132920FINISHERUpdated May 10, 2023

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

A Phase 3 interventional study of Dexamethasone and Placebo in Aneurysmal Subarachnoid Hemorrhage, sponsored by University Hospital, Bonn. Recruiting at 13 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by University Hospital, Bonn · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Dec 2021; still recruiting 4 years 10 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
334
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Aneurysmal Subarachnoid Hemorrhage
03

In context

Subarachnoid Hemorrhage

509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.

This study's planned enrollment of 334 is above the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.

Browse Subarachnoid Hemorrhage studies →

Lead sponsor

University Hospital, Bonn is the lead sponsor of 154 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
334 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DrugDexamethasone

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

  • DrugPlacebo

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

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

13 of 13 sites recruiting
  • Eberhard Karls University of Tübingen
    Tübingen, Baden Württemberg 72076, Germany
    • Constantin Roder, Prof. Dr. · Contact
    • Helene Hürth, Dr. · Contact
    Recruiting
  • University of Ulm/BKH Günzburg
    Günzburg, Bayern 89312, Germany
    • Ralph König, Prof. Dr. · Contact
    • Andrej Pala, PD Dr. · Contact
    Recruiting
  • Klinikum rechts der Isar, School of Medicine, Technical University of Munich
    München, Bayern 81675, Germany
    • Maria Wostrack, PD Dr. · Contact
    • Jens Gempt, Prof. Dr. · Contact
    Recruiting
  • University Medical Center Regensburg
    Regensburg, Bayern 93053, Germany
    • Karl-Michael Schebesch, Prof. Dr. · Contact
    • Sylvia Bele, Dr. · Contact
    Recruiting
  • Johann Wolfgang Goethe-Universität Frankfurt am Main
    Frankfurt, Hessen 60529, Germany
    • Marcus Czabanka, Prof. Dr. · Contact
    • Vincent Prinz, PD Dr. · Contact
    Recruiting
  • Hannover Medical School
    Hannover, Niedersachsen 30625, Germany
    • Florian Wild, Dr. · Contact
    • Elvis Hermann, PD Dr. · Contact
    Recruiting
  • University Hospital Bonn
    Bonn, NRW 53127, Germany
    • Hartmut Vatter, Prof. Dr. · Contact
    • Tim Lampmann · Contact
    Recruiting
  • University Hospital of Essen
    Essen, NRW 45147, Germany
    • Ramazan Jabbarli, PD Dr. · Contact
    • Marvin Darkhwah Oppong, PD Dr. · Contact
    Recruiting
  • University of Cologne
    Köln, NRW 50937, Germany
    • Roland Goldbrunner, Prof. Dr. · Contact
    • Marco Timmer, Dr. · Contact
    Recruiting
  • Otto von Guericke University Magdeburg
    Magdeburg, Sachsen-Anhalt 39120, Germany
    • Erol Sandalcioglu, Prof. Dr. · Contact
    • Ali Rashidi, Dr. · Contact
    Recruiting
  • University Hospital Leipzig
    Leipzig, Sachsen 04103, Germany
    • Erdem Güresir, Prof. Dr. · Contact
    • Dirk Lindner, PD Dr. · Contact
    Recruiting
  • Charité-Universitätsmedizin Berlin
    Berlin, 10117, Germany
    • Nils Hecht, PD Dr. · Contact
    • Lars Wessels, Dr. · Contact
    Recruiting
  • University Medical Center Hamburg-Eppendorf
    Hamburg, 20246, Germany
    • Patrick Czorlich, PD Dr. · Contact
    • Thomas Sauvigny, Dr. · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05132920
Lead sponsor
University Hospital, Bonn
Collaborators
German Federal Ministry of Education and Research, Pharmacy of the University Hospital Leipzig- AöR, nextevidence GmbH
Responsible party
Erdem Güresir, MD (Prof. Dr. Erdem Güresir, University of Leipzig) — Principal investigator
First posted
Nov 24, 2021
Start date
Dec 3, 2021
Primary completion
Dec 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
May 10, 2023

Study contacts

Erdem Güresir, Prof. Dr.
Contact
Erdem.Gueresir@medizin.uni-leipzig.de
0049 - 341 97 17500
Erdem Güresir, Prof. Dr.
principal investigator · Department of Neurosurgery, University Hospital Leipzig

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion