This phase III trial will establish whether IL-1Ra, with sub-cutaneous (SC) administration twice daily for up to 21 days post aneurysmal subarachnoid haemorrhage (aSAH), improves clinical outcome as measured by ordinal shift in mRS at 6 months. Patients with SAH transferred to a neurosurgical centre will be identified and approached for study participation. Following consent, patients will be randomised to receive either IL-1Ra or placebo for a maximum of 21 days from onset of symptoms. Patients who are found to be non-aneurysmal following randomisation will be withdrawn from the study treatment. Blood samples for plasma IL-6 will be obtained prior to randomisation and at day 3-5 post randomisation for IL-6 \& IL-1 measurement. Safety will be measured at 30 days post randomisation and outcome assessed at 6 months post randomisation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
612
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
Derriford Hospital
Plymouth, Devon, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Leeds General Infirmary
Leeds, Yorkshire, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Addenbrookes Hospital
Cambridge, United Kingdom
The Walton Centre
Liverpool, United Kingdom
Royal London Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
...and 7 more locations
Ordinal shift in modified Rankin Score (mRS)
Time frame: 6 months post randomisation
Measurement of mood using HADS
Time frame: 6 months post randomisation
Measurement of fatigue using Fatigue score
Time frame: 6 months post randomisation
Measurement of quality of life using EQ-5D-5L score
Time frame: 6 months post randomisation
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