Subarachnoid haemorrhage Circulatory System Subarachnoid haemorrhage
Conditions
Interventions
The study is a double-blind randomised controlled trial of Kineret® with participants with an external ventricular drain (EVD) inserted as part of their clinical care. Participants will be randomised
and at 6, 12 and 24 hours (during period of infusion) and then at 36, 48 and 72 hours (from time of bolus injection). A final sample will be obtained at Day 7 (study end) if the participant still has
Sponsors
Salford Royal Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 16 years or above 2. Patients with confirmed spontaneous subarachnoid haemorrhage (SAH) who have had an external ventricular drain (EVD) inserted as part of their clinical care 3. 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 4. No confirmed or suspected serious infection at the time of study entry 5. Renal function within normal limits (serum creatinine <177 µmol/l) 6. 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
Exclusion criteria
Exclusion criteria: 1. Known or suspected infection at the time of consideration for the study 2. 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 3. Previous or concurrent treatment with anakinra or Kineret®; known at the time of study entry 4. Previous or current treatment with medication suspected of interacting with Kineret®, such as TNF-á inhibitors 5. Evidence of serious infection 6. 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 7. Known pregnancy or breast-feeding 8. Clinically significant concurrent medical condition, which in the Chief Investigator's (or designee's) discretion, could affect the safety, tolerability, or efficacy in this study 9. Previous inclusion in current study (known prior to inclusion) 10. Inability or unwillingness of patient or patient's personal representative to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether intravenously administered Kineret® causes a decrease in the concentration of central inflammatory biomarkers in the blood and CSF samples following SAH compared to placebo. The following markers will be assessed: C-reactive protein (CRP), IL-1RA, IL-1a, IL-1ß, IL-6, IL-8, IL-10 Blood and CSF samples will be taken immediately prior to bolus dose of IMP/placebo (baseline); and at 6, 12 and 24 hours (during period of infusion) and then at 36, 48 and 72 hours (from time of bolus injection). A final sample will be obtained at Day 7 (study end) if the participant still has an EVD in-situ. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed