Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— FINISHER  

Official title:

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05132920
• Other study ID #: NCH-201803
• Secondary ID: 2021-000732-54
• Status: Recruiting
• Phase: Phase 3
• Start date: December 3, 2021
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University Hospital, Bonn
• Contact: Erdem Güresir, Prof. Dr.
• Phone: 0049 - 341 97 17500
• Email: Erdem.Gueresir[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. ß-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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Inflammation
• Subarachnoid Hemorrhage

Intervention

Drug:
• Dexamethasone
3 x 8 mg dexamethasone daily for days 1-7 and 1 x 8 mg dexamethasone daily for days 8-21
• Placebo
3 x 2 ml Placebo daily for days 1-7 and 1 x 2 ml Placebo daily for days 8-21

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin	Berlin
Germany	University Hospital Bonn	Bonn	NRW
Germany	University Hospital of Essen	Essen	NRW
Germany	Johann Wolfgang Goethe-Universität Frankfurt am Main	Frankfurt	Hessen
Germany	University of Ulm/BKH Günzburg	Günzburg	Bayern
Germany	University Medical Center Hamburg-Eppendorf	Hamburg
Germany	Hannover Medical School	Hannover	Niedersachsen
Germany	University of Cologne	Köln	NRW
Germany	University Hospital Leipzig	Leipzig	Sachsen
Germany	Otto von Guericke University Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Klinikum rechts der Isar, School of Medicine, Technical University of Munich	München	Bayern
Germany	University Medical Center Regensburg	Regensburg	Bayern
Germany	Eberhard Karls University of Tübingen	Tübingen	Baden Württemberg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Bonn	German Federal Ministry of Education and Research, nextevidence GmbH, Pharmacy of the University Hospital Leipzig- AöR

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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