SC IL-1Ra in Stroke Study
Research type
Research Study
Full title
Does subcutaneous interleukin-1 receptor antagonist reduce inflammation following ischaemic stroke compared to placebo?
IRAS ID
125105
Contact name
Pippa Tyrrell
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Eudract number
2013-001757-28
Research summary
This study builds on work undertaken by our group in developing a potential treatment for brain damage resulting from cerebral ischaemia (lack of oxygen to the brain) following ischaemic stroke or subarachnoid haemorrhage (SAH).
A protein, interleukin−1 (IL−1); a marker of inflammation (biomarker) is thought to trigger the damage following cerebral ischaemia. IL-1 can be blocked by another protein, interleukin−1 receptor antagonist (IL−1Ra), a naturally occurring anti-inflammatory. A manufactured form of IL-1Ra is available as Kineret® and this study aims to determine the effect of subcutaneously (SC) administered Kineret© on biomarkers in patients with ischaemic stroke compared to placebo.
We aim to recruit 80 participants within 6 hours of ischaemic stroke. Participants will receive twice-daily, SC injections of either Kineret© or placebo (double-blind, allocated using third-party randomisation). First injection of study drug will be given within 6 hours of stroke with 5 further doses administered at 12 hourly intervals for 3 days (six injections in total). All participants will receive standard care for ischaemic stroke, including treatment to dissolve the blood clot; known as thrombolysis (if clinically indicated). Baseline blood sample will be obtained at admission along with clinical blood samples, prior to consent to avoid delays to clinical care. Participants will undergo research assessments, together with four further blood samples for measurement of inflammatory biomarkers at pre-determined time points for 5-7 days. Blood samples from patients who decline study participation will be destroyed.
Analysis will determine whether SC administered Kineret© causes a decrease in the concentration of inflammatory biomarkers in the blood, primarily within 3 days post stroke and also at 5-7 days. Assessments at one month and three months will record the level of disability and length of hospital stay. We will collect safety data on all participants throughout the study.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
13/NW/0460
Date of REC Opinion
26 Sep 2013
REC opinion
Further Information Favourable Opinion