Reducing inflammation to improve outcomes after brain hemorrhage

Fight INflammation to Improve Outcome After Aneurysmal Subarachnoid HEmorRhage

This study is testing if giving an anti-inflammatory drug called dexamethasone to patients who have had a brain hemorrhage can help them recover better and avoid further complications.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 334 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bonn (Academic / other)
• Locations: 13 sites (Tübingen, Baden Württemberg and 12 other locations)
• Trial ID: NCT05132920 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of dexamethasone, an anti-inflammatory drug, to improve outcomes in patients who have suffered an aneurysmal subarachnoid hemorrhage (SAH). The study aims to address secondary injuries caused by inflammation, which may lead to delayed cerebral ischemia and poor patient outcomes. Participants will be randomly assigned to receive either dexamethasone or a placebo within 48 hours of their SAH diagnosis. The trial is multi-center, involving several prominent hospitals in Germany, and seeks to provide evidence for a treatment approach that is currently not recommended in clinical guidelines.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with aneurysmal SAH within 48 hours of onset.

Not a fit: Patients with SAH from causes other than aneurysm rupture or those with severe brain injuries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery and reduce complications for patients suffering from aneurysmal subarachnoid hemorrhage.

How similar studies have performed: While some studies suggest potential benefits of anti-inflammatory drugs in SAH, this approach is novel and has not been rigorously tested in randomized controlled trials.

Eligibility criteria

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

Where this trial is running

Tübingen, Baden Württemberg and 12 other locations

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

Study contacts

• Principal investigator: Erdem Güresir, Prof. Dr. — Department of Neurosurgery, University Hospital Leipzig
• Study coordinator: Erdem Güresir, Prof. Dr.

Conditions Aneurysmal Subarachnoid Hemorrhage