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non-aneurysmal following randomisation will be withdrawn from the study treatment.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.
Phase:
Phase 3
Details
Lead Sponsor:
University of Manchester
Collaborators:
Manchester Academic Health Science Centre National Institute for Health Research, United Kingdom Salford Royal NHS Foundation Trust