SC IL-1Ra in SAH

• Research type

  Research Study

• Full title

  Does subcutaneous interleukin-1 receptor antagonist reduce inflammation following subarachnoid haemorrhage?

• IRAS ID

  79619

• Contact name

  Pippa Tyrrell

• Sponsor organisation

  Salford Royal Hospitals NHS Foundation Trust

• Eudract number

  2011-001855-35

• ISRCTN Number

  applied for

• Research summary

  This study builds on previous work undertaken by our group in developing a potential treatment for brain damage resulting from cerebral ischaemia (lack of oxygen to the brain) following stroke or subarachnoid haemorrhage (SAH). A protein called 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 SAH. We aim to recruit 140 participants with SAH within 72 hours of haemorrhage. Half the recruited participants (allocated using third-party randomisation) will receive twice-daily, SC injections of Kineret. Injections will start as soon as possible after admission to hospital (not later than 72 hours after haemorrhage) and will continue for a maximum of 21 days post-haemorrhage or discharge from hospital. All participants will receive standard care for SAH and inclusion in the study will not delay or interfere with clinical care. All participants will have research assessments together with blood sampling for measurement of inflammatory biomarkers at pre-determined time points until 21 days post haemorrhage or discharge (if earlier).The analysis will determine whether SC administered Kineret causes a decrease in the concentration of inflammatory biomarkers in the blood, primarily between 3-8 days post haemorrhage and also at days 14 and 21 post haemorrhage. By contacting all participants at six months post haemorrhage, we will compare outcome and recovery in both patients groups. We will collect safety data on all participants throughout the study.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  11/NW/0390

• Date of REC Opinion

  9 Aug 2011

• REC opinion

  Further Information Favourable Opinion