Using Anakinra to Reduce Brain Damage After Hemorrhagic Stroke

Anakinra in Cerebral Haemorrhage to Target Secondary Injury Resulting From Neuroinflammation - a Phase II Clinical Trial

This study is testing if the medication anakinra can help reduce brain damage and improve recovery in people who have had a hemorrhagic stroke.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Radboud University Medical Center (other)
• Locations: 1 site (Nijmegen)
• Trial ID: NCT04834388 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of anakinra, a medication that blocks inflammatory responses, in reducing secondary brain damage caused by spontaneous intracerebral hemorrhage (ICH). Participants will be randomly assigned to receive either high-dose, low-dose anakinra, or standard medical care within eight hours of symptom onset. The study will assess the formation of perihaematomal edema using MRI scans after one week and monitor safety and inflammatory markers over the treatment period. Additionally, functional outcomes will be evaluated through follow-up interviews three months post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed spontaneous intracerebral hemorrhage and a minimum hemorrhage volume of 10 mL.

Not a fit: Patients with severe ICH unlikely to survive the first 72 hours or those requiring immediate neurosurgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from spontaneous intracerebral hemorrhage.

How similar studies have performed: While the use of anakinra in this context is novel, previous studies have shown its effectiveness in other inflammatory conditions, suggesting potential for success in this application.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. Supratentorial non-traumatic ICH confirmed by CT, without a confirmed causative lesion on admission CT-angiography (e.g. aneurysm, AVM, DAVF, cerebral venous sinus thrombosis) or other known underlying lesion (e.g. tumour, cavernoma);
3. Minimal intracerebral haemorrhage volume of 10 mL;
4. Intervention can be started within 8 hours from symptoms onset;
5. Patient's or legal representative's informed consent.

Exclusion Criteria:

1. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score \< 6 at time of consent);
2. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct;
3. Planned neurosurgical haematoma evacuation;
4. Severe infection at admission, requiring antibiotic treatment;
5. Known active tuberculosis or active hepatitis;
6. Use of immunosuppressive or immune-modulating therapy at admission (see 15.1 Appendix A);
7. Neutropenia (Absolute Neutrophil Count (ANC) \<1.5 x 109/L );
8. Pre-stroke modified Rankin Scale score ≥ 3;
9. Pregnancy or breast-feeding;
10. Standard contraindications to MRI (see 15.2 Appendix B);
11. Known prior allergic reaction to gadolinium contrast or one of the constituents of its solution for administration;
12. Known allergy to anakinra or other products that are produced by DNA technology using the micro-organism E. coli;
13. Live vaccinations within the last 10 days prior to this ICH;
14. Severe renal impairment (eGFR \<30ml/min/1.73m)
15. Active malignancy

Where this trial is running

Nijmegen

• Radboudumc — Nijmegen, Netherlands (RECRUITING)

Study contacts

• Principal investigator: F.H.B.M. Schreuder, MD PhD — Radboud University Medical Center
• Study coordinator: Floris H.B.M Schreuder, MD PhD

Conditions: Intracerebral Hemorrhage