An open-label study of the cerebrospinal fluid pharmacokinetics of intravenous Kineret® (recombinant methyionyl human interleukin-1 receptor antagonist [r-metHuIL-1RA]) in patients with subarachnoid haemorrhage
- Conditions
- Subarachnoid haemorrhageCirculatory System
- Registration Number
- ISRCTN45931429
- Lead Sponsor
- Salford Royal Foundation Hospital Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1. Patients with confirmed spontaneous subarachnoid haemorrhage who require the placement of an external ventricular drain
2. No other health problems that in the opinion of the Investigator would interfere with participation, administration of study treatment or assessment of outcomes
3. No confirmed or suspected serious infection
4. Renal function within normal limits
5. Aged 16 or above
6. Willing and able to give consent to take part or consent available from the patient?s representative
7. Likely to remain within the study centre for the next 7 days
1. Known allergy to E. coli or constituents of the investigational medicinal product
2. Previous or current treatment with Kineret® or anakinra
3. Previous participation in a clinical trial involving anakinra
4. Previous or current treatment potentially interacting with anakinra
5. Previous participants in other clinical intervention trials (within 30 days of last intervention)
6. Known to be pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method