Cerebral hemmorhage hemorrhagic stroke
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria: 1. Severe ICH, unlikely to survive the first 72 hours (defined as Glasgow Coma Scale score = 3; 9. Pregnancy or breast-feeding; 10. Standard contraindications to MRI; 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. Vaccinations with live attenuated microorganisms within the last 10 days prior to this ICH; 14. Severe renal impairment (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome is effect anakinra compared to standard medical care on perihematomal oedema (measured as oedema extension distance on MRI at day 7). Secondly, we will compare the effect on oedema extension distance of the high dose versus the low dose anakinra groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters are to determine whether anakinra alters the level of serum inflammation markers and the blood barrier leakage Ktrans as measured with DCE-MRI on day 7. Furthermore to determine the safety profile of anakinra in sICH and to test whether it influences the clinical outcome in sICH at 90 days. | — |
Countries
Netherlands
Outcome results
None listed