TITAN-TBI
Research type
Research Study
Full title
Modulating interleukin-6 pathways to understand the effect of systemic inflammation on detrimental neuroinflammation following Traumatic Brain Injury
IRAS ID
1009886
Contact name
Edward Needham
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
ISRCTN Number
ISRCTN16877626
Research summary
Too much inflammation in the brain is thought to worsen recovery after a head injury, and we think that reducing inflammation might improve patients’ outcomes. This study is looking to understand whether treatment with an anti-inflammatory medicine (tocilizumab) might be helpful after head injury. Tocilizumab is commonly used in other illnesses such as rheumatoid arthritis and more recently it has been shown to be effective in treating severe COVID-19.
This study will recruit a total of 60 participants at Cambridge University Hospitals NHS Foundation Trust, over two working packages which will be ran in parallel (with 10 participants recruited into work package 1, and 50 participants recruited into work package 2), who have suffered a head injury that means they have had to go to intensive care and have a drain in their brain that measures brain inflammation.
If recruited to work package 1, participants will receive either a single dose of Tocilizumab or the normal care given to patients with head injury. If recruited to work package 2, participants will randomly (i.e. by chance) be allocated to receive a single dose of either Tocilizumab or a salt water placebo, alongside the usual care given to patients with head injury. For work package 2, the first 14 participants will be recruited to the open-label portion of the work package (where treatment allocation will be known), after which the following 36 participants will be recruited to the double-blind portion of the work package (where participants are randomly assigned placebo or tocilizumab treatment). In both stages, participants will be followed up for 6 months.
As this is the first study looking at Tocilizumab in head injury, we are focussing on whether it reduces inflammation in the brain and whether we can detect a beneficial effect via blood samples. If the study is successful, we will plan to undertake a larger study to investigate definitively whether it improves recovery from head injury.REC name
East of England - Essex Research Ethics Committee
REC reference
26/EE/0024
Date of REC Opinion
12 Mar 2026
REC opinion
Further Information Favourable Opinion