A single centre phase II study of Interleukin 1 receptor antagonist in the treatment of severe Traumatic Brain Injury - Interleukin-1 Receptor Antagonist in Severe Traumatic Brain Injury

Phase 1

• Conditions: Severe Traumatic Brain Injury; MedDRA version: 9.1 Level: LLT Classification code 10060690 Term: Traumatic brain injury

• Registration Number: EUCTR2005-005707-42-GB
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust and University of Cambridge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-30
• Study Completion: 2011-12-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified