SC IL-1Ra in SAH - phase III trial
Research type
Research Study
Full title
Does Interleukin-1 Receptor Antagonist Improve Outcome following aneurysmal Subarachnoid Haemorrhage (aSAH)? A Phase III trial
IRAS ID
214739
Contact name
Andrew King
Contact email
Sponsor organisation
University of Manchester
Eudract number
2016-003725-42
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
R121178, Sponsor reference number
Duration of Study in the UK
4 years, 7 months, 31 days
Research summary
Subarachnoid haemorrhage (SAH) is most commonly caused when an abnormal bulge in the wall of a blood vessel on the surface of the brain ruptures. It affects up to 6,000 people every year in the UK. Up to half of all patients do not survive long enough to receive hospital treatment and those who do survive; many suffer long-term issues that impact on their daily life and return to work e.g. fatigue, attention and memory problems. aSAH in 2005 was estimated to cost £205m annually with community health and social service care estimated to be around 18% of the total. Any treatment that improves clinical outcome would be cost effective.
We know from previous studies that inflammation in the brain and blood vessels is high after aSAH. We also know that it is possible to reduce, block and even reverse this inflammation by giving a man-made version of a protein called interleukin-1 receptor antagonist (IL-1Ra). This clinical trial will evaluate whether or not treatment with interleukin-1 receptor antagonist (IL-1Ra), improves clinical outcome following aSAH.
We aim to recruit 800 patients within 72 hours of aSAH from 20 neurosurgical centres in the United Kingdom over 3 ½ years. Participants will be randomly allocated to receive twice-daily injections of IL-1Ra or dummy drug (placebo) for a maximum of 21 days after SAH or discharge from hospital. Blood tests taken at randomisation and after 3 days of treatment will check levels of inflammation. Safety will be confirmed at 30 days and levels of disability, mood, fatigue and quality of life will be checked at 6 months using standard questionnaires conducted over the telephone.
This proposed study will provide clear evidence on whether or not inflammation is associated with outcome. If positive, the results may offer real hope in the treatment of aSAH in the near future.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0581
Date of REC Opinion
3 Nov 2017
REC opinion
Further Information Favourable Opinion