Traumatic brain injury Injury, Occupational Diseases, Poisoning Intracranial injury
Conditions
Interventions
Participants are randomised to receive 5 days of 100 mg IL-1ra (Kineret) subcutaneously once a day or a placebo.
Clinical follow-up at 6 months.
Sponsors
Cambridge University Hospitals NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Severe traumatic brain injury 2. Aged 16 - 65 years, either sex 3. Abnormal computed tomography (CT) scan requiring sedation, paralysis, ventilation and multi-modality monitoring as part of clinical care
Exclusion criteria
Exclusion criteria: 1. Head injury unlikely to survive 5 days, e.g. bilaterally fixed dilated pupils 2. Follow up not possible 3. Not suitable for insertion of cranial access device, e.g. bleeding diathesis 4. Immunosuppression 5. Severe renal insufficiency 6. Pregnancy/nursing mothers 7. Known hypersensitivity to E. Coli derived products 8. Adminstration of live vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: based on adverse events, follow-up assessment of outcome at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. IL-1ra, IL-1alpha, IL-1beta, IL-6, IL-8 in serum and by cerebral microdialysis, measured by 4-hourly serum markers twice daily 2. Cerebral lactate, pyruvate, glucose, glutamate, glycerol by cerebral microdialysis, measured by 4-hourly serum markers twice daily 3. Clinical follow-up at 6 months, Glasgow Outcome Scale (GOS) and 36-item Short Form Health Survey (SF-36) | — |
Countries
United Kingdom
Outcome results
None listed