AzTrials
AzTrials

Aneurysmal Subarachnoid HemorrhagePhase 3FINISHERNCT05132920

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

A Phase 3 study testing Dexamethasone in people with Aneurysmal Subarachnoid Hemorrhage, run by University Hospital, Bonn at 13 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Dexamethasone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
13 sitesGermany
Study dates
3 Dec 2021to 9 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Charité-Universitätsmedizin Berlin

    Berlin, 10117

  • University Hospital Bonn

    Bonn, North Rhine-Westphalia, 53127

  • University of Cologne

    Cologne, North Rhine-Westphalia, 50937

  • University Hospital of Essen

    Essen, North Rhine-Westphalia, 45147

  • Johann Wolfgang Goethe-Universität Frankfurt am Main

    Frankfurt am Main, Hesse, 60529

  • University of Ulm/BKH Günzburg

    Günzburg, Bavaria, 89312

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

  • Hannover Medical School

    Hanover, Lower Saxony, 30625

  • University Hospital Leipzig

    Leipzig, Saxony, 04103

  • Otto von Guericke University Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

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

    München, Bavaria, 81675

  • University Medical Center Regensburg

    Regensburg, Bavaria, 93053

  • Eberhard Karls University of Tübingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

About this study

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.

Being tested
Dexamethasone, Placebo
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

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

  • PlaceboDrug

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

Study groups in NCT05132920
Study groupRoleWhat they receive
Experimental armExperimental3 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
Receives: Drug: Dexamethasone
Control armPlacebo comparator3 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2021
  2. Study start3 Dec 2021
  3. Primary completion9 Sep 2024
  4. Study completion9 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
334 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05132920
Sponsor's protocol ID
NCH-201803
Other IDs
2021-000732-54
Acronym
FINISHER
Status last verified
Oct 2026
First submitted
2 Nov 2021
Last updated
2 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35361026

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with Aneurysmal Subarachnoid Hemorrhage, run by University Hospital, Bonn at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale (mRS) at 6 months after SAH (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05132920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in