BLOC-ICH / Hospitals and staff / Checking the eligibility of participants

Inclusion criteria

  1. Patients with spontaneous, primary, supratentorial ICH admitted to a participating centre within 8 hours of symptom onset.
  2. No concomitant health problems that, in the opinion of the PI or designee, would interfere with participation, administration of study drug or assessment of outcomes including safety.
  3. Willing and able to give informed consent or consent available from a patient representative for trial inclusion including agreement in principle to receive study drug and undergo all study assessments.
  4. Male or female aged 18 years or above.

Exclusion criteria

  1. Severe ICH, unlikely to survive to 72 hours scan (defined as Glasgow Coma Scale score ≥6 at any time prior to consent).
  2. Confirmed or suspected structural abnormality as cause of ICH (including tumour, vascular malformation).
  3. Confirmed or suspected haemorrhagic transformation of an arterial or venous infarct.
  4. Acute neurosurgery planned <72 hours of admission.
  5. Known active tuberculosis or active hepatitis.
  6. Known active malignancy.
  7. Neutropenia (neutrophil count (ANC) <1.5 x 109/L).
  8. Abnormal renal function (previous eGFR >32 mL/min in 3 months prior to this ICH.
  9. Live vaccinations within the last 10 days prior to this ICH.
  10. Previous or concurrent treatment with IL-1Ra known at the time of trial entry or previous participation in this trial.11. Previous or current treatment with medication suspected of interacting with IL-1Ra, listed in the drug SmPC.
  11. Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or 5 half-lives of enrolment (whichever is longer) of ictus, or for the period determined by the protocol of the trial / study the patient has taken part in.
  12. Known to be pregnant or breast-feeding or inability to reliably confirm that the patient is not pregnant.
  13. Known diagnosis of Still’s disease.
  14. Clinically significant serious concurrent medical condition, premorbid illnesses, or concurrent serious infection, at the PI’s (or designee’s) discretion, which could affect the safety or tolerability of the intervention.
  15. Known allergy to IL-1Ra or any of the excipients listed in the drug SmPC.
  16. Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. E.coli derived protein).

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