IL-1RA IN SAH BIOMARKER STUDY

• Research type

  Research Study

• Full title

  The effect of Kineret on brain biomarkers in patients with subarachnoid haemorrhage

• IRAS ID

  1360

• Sponsor organisation

  Salford Royal Hospitals NHS Foundation Trust

• Eudract number

  2007-005836-98

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  This project forms part of a programme of research that aims to evaluate the efficacy of a treatment to treat the consequences of lack of oxygen to the brain (cerebral ischaemia), caused by stroke or subarachnoid haemorrhage (SAH). Study 1 identified the optimum Kineret dose required to achieve therapeutic levels in braiflud at 30 minutes post injection. This study (study 2) should identify how effective this dose will be.Interleukin-1?(IL-1), a marker of inflammation (biomarker) is thought to trigger the damage following cerebral ischaemia and can be blocked by Interleukin-1?receptor antagonist (IL-1RA), a naturally occurring antagonist. A manufactured form of this is Kineret© and this study will compare this to placebo in patients with SAH.Eligible participants will be randomised to receive either Kineret or placebo as a bolus injection into a vein (IV) over 1 minute followed by an infusion of Kineret or placebo in saline over 24 hours.Patients will only be eligible to participate if they have an external ventricular drain (EVD) inserted as part of their clinical care. The EVD allows excess cerebrovasculaflud (CSF) to drain away and reduced swelling within the brain after SAH. Before the bolus of IL-1RA/placebo is given, samples of CSF will be taken from the EVD, together with blood samples from existing peripheral lines and will be analysed for concentrations of markers of inflammation. This sampling of blood and CSF will be repeated at regular time points during and after the infusion. The analysis will determine whether IV administered Kineret caused a decrease in the concentration of inflammatory biomarkers within the brain compared to placebo.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/1

• Date of REC Opinion

  29 Jan 2009

• REC opinion

  Further Information Favourable Opinion