Interleukin-1 receptor antagonist in severe traumatic brain injury

Phase 2

Completed

• Conditions: Traumatic brain injury; Injury, Occupational Diseases, Poisoning; Intracranial injury

• Registration Number: ISRCTN88597330
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-24
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 26

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety: based on adverse events, follow-up assessment of outcome at 6 months.

Secondary Outcome Measures

Name	Time	Method
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<br>2. Cerebral lactate, pyruvate, glucose, glutamate, glycerol by cerebral microdialysis, measured by 4-hourly serum markers twice daily<br>3. Clinical follow-up at 6 months, Glasgow Outcome Scale (GOS) and 36-item Short Form Health Survey (SF-36)