Anakinra in Cerebral haemorrhage to Target secondary Injury resulting from Neuroinflammation - a phase II clinical trial

Phase 2

Recruiting

Conditions: Cerebral hemmorhage
hemorrhagic stroke
10007963

Registration Number: NL-OMON52254

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

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;
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 <30ml/min/1.73m);
15. Known active malignancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is effect anakinra compared to standard medical care on<br /><br>perihematomal oedema (measured as oedema extension distance on MRI at day 7).<br /><br>Secondly, we will compare the effect on oedema extension distance of the high<br /><br>dose versus the low dose anakinra groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are to determine whether anakinra alters the level<br /><br>of serum inflammation markers and the blood barrier leakage Ktrans as measured<br /><br>with DCE-MRI on day 7. Furthermore to determine the safety profile of anakinra<br /><br>in sICH and to test whether it influences the clinical outcome in sICH at 90<br /><br>days. </p><br>