TITAN-TBI

Targeted Interleukin-6 Therapy Against Neuroinflammation

Modulating interleukin-6 pathways to understand the effect of systemic inflammation on detrimental neuroinflammation following Traumatic Brain Injury.

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, over two stages, 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.

In the first stage, participants will receive either a single dose of Tocilizumab or the normal care given to patients with head injury. In the second stage, 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. 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 definitely whether it improves recovery from head injury.

Main inclusion criteria

  • Have had Legal Representative consent given;
  • Be aged 18 years or older;
  • Have moderate to severe TBI (Glasgow Coma Scale (GCS)<13);
  • Able (in the Investigator's opinion) to comply with all trial requirements.

Main exclusion criteria

  • Brain-injury or co-morbidity deemed incompatible with survival;
  • 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);
  • Known allergy to Tocilizumab or any of its excipients;
  • Septic shock;
  • Perforated viscus on cross-sectional imaging;
  • Neutropoenia<1x109/litre;
  • Hepatic enzymes>10x upper limit of normal;
  • Thrombocytopoenia<50x103/microlitre;
  • Known pre-existing immunosuppression medications (e.g. immunotherapy) or immunodeficiency disorder (n.b. adequately treated HIV ≠ exclusion criteria);
  • Pregnancy/breast-feeding mothers;
  • Received Tocilizumab or any other investigational drug within 30 days prior to the screening visit;
  • Any other significant disease, disability or investigational result which, in the opinion of the Investigator, may either put the participants at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.

Chief investigator

Chief Investigator: Dr Edward Needham

Contact details

Clinical Trials Coordinator: Bronwen Harry, George Pettitt

Email: [email protected]