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Researchers at the University of Oxford have been awarded a grant from the National Institute for Health and Care Research (NIHR) to investigate whether anti-tumour necrosis factor (TNF) therapy can reduce or prevent post operative delirium/cognitive deficit.

A plastic skull with a plastic brain inside

Post-operative delirium is an important problem, recognised as the most common surgical complication in older adults, occurring following many types of surgery. According to U.K. national audit data, 25% of all hip fracture patients develop post-operative delirium. Hip fracture patients who develop delirium are unfortunately twice as likely to die while in hospital and nearly four times more likely to require nursing home care compared with those who do not have delirium. Patients who develop delirium are approximately 4 times more likely to develop cognitive memory deficit over 3 years, increasing to 8-fold higher likelihood over 8 years. There are approximately 70,000 hip fractures each year in the U.K. and approximately 300,000 hip fractures in the U.S. each year.

A team from the University of Oxford has found that the trauma associated with surgery leads to the release of proinflammatory mediators, especially TNF, which in turn leads to inflammation of a part of the brain called the hippocampus. The hippocampus is involved in memory and is associated with learning and emotions. The new trial will explore whether necrosis factor (TNF) therapy can reduce or prevent post operative delirium/cognitive deficit ("post-operative delirium").

Professor Matt Costa at NDORMS, University of Oxford will lead the trial. He is a trauma orthopaedic surgeon with extensive expertise in clinical trials especially in hip fracture. "Delirium is a terrible condition where patients get very confused and forget where and even who they are. It's very distressing for the patients but also for their relatives. While most patients recover in the days after surgery, we now know that some patients with delirium develop permanent symptoms. This new trial is very exciting. If we can reduce the severity of delirium after surgery, we should be able to improve the long-term quality of life for this important group of patients."

The trial is jointly funded by NIHR and 180 Life Sciences, a clinical stage biotech company, with support from the Oxford Biomedical Research Centre (BRC). It is expected to be open for enrolment in the first half of 2023.

"This is a major achievement by the team," said Dr. Jim Woody, CEO of 180 Life Sciences. "This dual funding model and collaboration between academia and industry leverages the expertise of both to develop new therapeutic strategies, for what we believe is a major unmet medical need, in the most effective way to benefit patients in the shortest possible timescale."

Prof Sir Marc Feldmann, co-chairman of 180 Life Sciences said: "It is a pleasure to see that 180 Life Sciences is following in my past footsteps where, in the 1990s, I pioneered, the use of anti-TNF in rheumatoid arthritis and 180 LS is now developing a whole series of new uses for anti-TNF, a very effective and safe medication."

The trial potentially fills an important unmet need which affects a significant number of patients worldwide and will be increasingly important preventative treatment as the population ages. The study is designed as a multi-center, randomised placebo-controlled trial in patients with hip fracture aged 60 years and above.

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