Subcutaneous interleukin-1 receptor antagonist (SC IL-1RA) in Stroke Study

INTERVENTION: Participants will receive twice daily, SC injections of either Kineret© or placebo. Added 06/04/2017: Participants will be randomised to subcutaneous administered of Kineret (anakinra) or placebo by a third‐party, web‐based computerised system. All participants will receive the first dose of study treatment (Kineret or placebo) within 6 hours of stroke onset. Five further doses will be given at 12 hourly intervals; a total of 6 injections over 72 hours. A blood sample will be obtained prior to randomisation and this will be repeated at 7am on the following 3 days. This will be used to measure levels of inflammation in the blood. Participation in the study will not delay clinical care or discharge from the hospital. All participants will be contacted by telephone at 30 days post‐stroke, to check for adverse events and at 3 months post‐stroke to measure recovery or level of ability using a standard questionnaire called modified Rankin Scale. This will complete study participation. CONDITION: Topic: Stroke Research Network; Subtopic: Acute Care; Disease: In hospital study ; Nervous System Diseases ; Stroke PRIMARY OUTCOME: Current primary outcome measures as of 06/04/2017:; Level of IL6, using ELISA within 3 days of stroke onset; ; Previous primary outcome measures:; Reduction in inflammatory biomarkers; Timepoints: Between 6 hours and 5‐7 days post stroke SECONDARY OUTCOME: Added 06/04/2017:; 1. Levels of other inflammatory markers, measured using ELISA or Luminex at within 3 days of stroke onset; 2. Clinical outcome at 3 months following ischaemic stroke, measured using:; 2.1. The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS); 2.2. The modified Rankin Score (mRS); 2.3. Survival (mortality) , measured using hospital records; 2.4. Length of hospital stay (LOS), measured using a telephone survey INCLUSION CRITERIA: 1. Patients with confirmed ischaemic stroke who are admitted to the Comprehensive Stroke Centre at Salford Royal NHS Foundation Trust (SRFT) where consent can be obtained and drug administered within 6 hours 2. National Institutes of Health stroke scale (NIHSS) score between 4‐26 3. No concomitant health problems that, in the opinion of the Principal Investigator (PI) or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, preexisting malignancy 4. Renal function within normal limits (< 177 µmol/l) 5. Willing and able to give informed consent or consent available from a patient representative (personallegal) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments 6. Aged 18 years or above Healthy volunteers (recruited to provide a one‐off 20ml blood sample only) 1. Between 18 and 80 years, in good h