Traumatic brain injury Injury, Occupational Diseases, Poisoning
Conditions
Interventions
WP1: 10 participants will be recruited to an open-label, non-randomised portion of the trial.
1. Treatment arm: The first 5 participants enrolled into WP1 will receive a single dose of tocilizumab, in
Sponsors
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: The main inclusion criteria for both WPs are as follows: 1. Have had Legal Representative consent given 2. Be aged 18 years or older 3. Have moderate to severe post-resuscitation TBI (Glasgow Coma Scale (GCS) <13) Additional inclusion criteria for WP1 are: 1. Have an external ventricular drain (EVD) and a catheter sited for clinical care Additional inclusion criteria for WP2 are: 1. Have a CMD catheter in situ (or plan to site within the requisite timeframe for investigational medicinal product administration i.e. 48 hours post-injury)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/03/2026: The main exclusion criteria for both WPs are as follows: 1. Brain injury or comorbidity deemed incompatible with survival 2. Timing of injury such that it is clear IMP/placebo could not be delivered within 48 hours (e.g., delayed secondary transfer from peripheral hospital; WP2 only) 3. Known allergy to tocilizumab or any of its excipients 4. Contraindications of the IMP as listed in the Summary of Product Characteristics (SmPC) 5. Weight 5x upper limit of normal at screening 10. Thrombocytopoenia 10x upper limit of normal at screening 10. Thrombocytopoenia <50 x 10³ / microlitre at screening 11. Actively taking immunosuppression medications (e.g. immunotherapy) or known immunodeficiency disorder (N.B. adequately treated HIV ? exclusion criterion) 12. Pregnant or breastfeeding 13. Received tocilizumab or any other investigational drug within 30 days prior to the screening visit 14. Use of medication metabolised by CYP450 3A4, 1A2 or 2C9 which, in the opinion of the investigator, will put the participant at risk if the drug level would significantly decrease for a period of time following a single dose of tocilizumab 15. Any other significant disease, disability or investigation result which, in the opinion of the Investigator, may either put the participant at risk, or may influence the result of the trial, or the participant’s ability to participate in the trial
Countries
England, United Kingdom
Contacts
Public ContactStudy Team
Outcome results
None listed