The effect of Kineret® on
brain biomarkers in patients with subarachnoid haemorrhage
Primary objective
To determine whether IV administered Kineret® inhibits the central nervous system (CNS) inflammatory response in patients with SAH
Study design
Double blinded randomised controlled trial
Inclusion criteria
- Patients with confirmed spontaneous SAH who have had an EVD inserted as part of their clinical care, that is expected to remain in situ for more than 48 h.
- Patients likely to remain resident within the centre for the next seven days.
- No concomitant health problems that, in the opinion of the Principal Investigator or Chief Investigator or designee, would interfere with participation, administration of study treatment or assessment of outcomes including safety, for example, pre-existing malignancy.
- No confirmed or suspected serious infection at the time of study entry.
- Renal function within normal limits (serum creatinine < 177 μmol l-1).
- Willing and able to give informed consent or consent available from a patient representative (personal, usually the next of kin) for study inclusion including agreement in principle to receive study intervention and undergo all study assessments.
- Aged 16 years or above.
Exclusion criteria
- Known or suspected infection at the time of consideration for the study.
- Known allergy to E. coli or any of the constituents of the study medication as established from the patient themselves, reliable representative and clinical records.
- Previous or concurrent treatment with Anakinra or Kineret®, known at the time of study entry.
- Previous or current treatment with medication suspected of interacting with Kineret®, such as TNF-α inhibitors.
- Evidence of serious infection.
- Known to have participated in a clinical trial of an investigational agent or device in the previous 30 days or for the period determined by the protocol of the study the patient has taken part in.
- Known pregnancy or breast-feeding.
- Clinically significant concurrent medical condition, at the Chief Investigator’s (or designee’s) discretion, which could affect the safety, tolerability, or efficacy in this study.
- Previous inclusion in the current study (known prior to inclusion).
- Inability or unwillingness of patient or patient’s personal representative to give written informed consent
Further details
Brain Injury Research Team
CSB, Salford Royal Foundation Hospital NHS Trust
Stott Lane
Salford
M6 8HD
Tel: 0161 206 5755
Fax: 0161 707 6534
Email: misah@manchester.ac.uk
Randomisation service provided by: Sealed Envelope™.com