Severe Traumatic Brain Injury MedDRA version: 9.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury
Conditions
Interventions
Trade Name: Kineret
Product Name: Kineret
Pharmaceutical Form: Solution for injection
Sponsors
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with head injury aged 16-65 years with an abnormal CT scan requiring intracranial pressure monitoring. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Head injury unlikely to survive 5 days -CT evidence of above as judged by clinical team -bilateral fixed and dilated pupils 2.follow up not possible 3. Not suitable for insertion of Cranial Access Device -bleeding diathesis 4.Immunosuppression -evidence of neutropenia -immunosuppression secondary to immunomodulatory medications, chemotherapy or radiation therapy in the 3 months preceding study entry 5.Severe Renal Insufficiency or End Stage Renal Disease -Defined as a Creatinine Clearance<30ml/min 6. Pregnancy/Nursing mothers 7. Known hypersensitivity to E. coli derived products 8. Administration of live vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is interleukin-1 receptor antagonist safe in the severely head injured patient population? We hypothesise that administration of IL1ra subcutaneously will be safe in the severe head injury population. Our secondary hypotheses are that subcutaneous administration will lead to rapid increases in brain tissue IL-1ra concentration (1) and that this will have a consequent biological effect on cerebral inflammation as measured by cerebral microdialysis parameters, sampling of cerebrospinal fluid (where available) and multi-modality monitoring (2). 1) Goldbach-Mansky et al. Neonatal-Onset Multisystem Inflammatory Disease Responsive to Interleukin 1Beta Inhibition. NEJM 2006 355;6 581-592 2) Kett-White et al. Multi-Modal Monitoring of Acute Brain Injury. Advances and Technical Standards in Neurosurgery 2001 27 87-134 ; Secondary Objective: 1. Does interleukin-1 receptor antagonist (IL-1ra) enter the brain in severely head injured patients when administered systemically? 2. What concentration of interleukin-1 receptor antagonist are achieved in the brain following subcutaneous administration and over what time course? (Pharmacokinetics) 3. Does administration of interleukin-1 receptor antagonist alter cerebral chemistry in brain extracellular fluid and cerebrospinal fluid? (A number of measured metabolites within the brain are thought to reflect underlying brain ischaemia/damage) 4. Does administration of interleukin-1 receptor antagonist alter the concentration of endogenous cytokines known to co-ordinate inflammation and damage in the brain? 5. Does administration of interleukin-1 receptor antagonist alter the physiological variables that are monitored and controlled in the management of head injury patients? ;Primary end point(s): Safety of subcutaneously administered IL-1ra in the severe head injury popu | — |
Countries
United Kingdom
Outcome results
None listed