WHiTE13-DECI: An investigation of people 60 years and over with a broken hip to determine whether they are less likely to have delirium after hip surgery if we treat them with infliximab during the operation
A broken hip is a serious injury that usually needs an urgent operation. About one in four patients develop a temporary state of severe confusion, known as delirium, around the time of surgery. Delirium can be very frightening, slows down healing, and often leads to longer hospital stays. Doctors believe delirium may be triggered by swelling and inflammation in the body and brain caused by the injury and operation. This study, called WHiTE13-DECI, is testing whether a drug called infliximab can prevent it. Infliximab is an anti-inflammatory medicine already widely used in the NHS for other conditions. During surgery, 416 patients across the UK will receive either a single dose of infliximab or a dummy treatment through a drip. Researchers will check participants' thinking and memory over the first five days, and follow their health and quality of life for a year.
At a glance
What is this study about?
A broken hip is a sudden, painful injury that mostly affects older adults. In almost all cases, an operation is needed to fix or replace the bone so the person can stand and walk again. However, around a quarter of people experience sudden confusion, called delirium, around the time of their surgery. Delirium makes it hard to think clearly, remember things, or understand what is happening. It can be deeply upsetting for patients and their families, and it is linked to longer hospital stays and slower recovery.
Researchers believe that the shock of a broken bone, combined with surgery, causes a sudden wave of inflammation across the body and in the brain. This brain swelling may be the main cause of post-surgery confusion. To tackle this, doctors are testing a medicine called infliximab. Infliximab is a well-known, powerful anti-inflammatory drug that has been used safely in the NHS for years to treat conditions like severe arthritis and bowel inflammation.
In this trial, patients having hip fracture surgery will receive a single dose of infliximab or a harmless salt-water placebo through a drip while in the operating room. By calming the body's inflammatory response immediately, doctors hope to protect the brain and prevent delirium before it can take hold.
If the study shows good results, this simple, single treatment could become part of routine NHS care. Preventing delirium would help older patients wake up with a clearer mind, start walking sooner, and return home more quickly with less risk of long-term memory complications.
Key takeaways
- The trial looks at preventing sudden confusion (delirium) in people aged 60 and over having hip surgery.
- Participants receive either a single dose of infliximab or a dummy liquid through a drip during their operation.
- Researchers check your memory and thinking over your first five days in hospital.
- Follow-up checks track your walking and recovery over the next 12 months.
- Taking part is completely voluntary and will not delay your operation or change your standard NHS care.
Who may be eligible?
This study is open to men and women aged 60 and over who have broken a hip and need surgery at a participating NHS hospital.
To ensure participant safety, some people cannot take part. This includes anyone with severe kidney or liver disease, severe heart failure, or conditions that affect the nervous system, such as multiple sclerosis. People who have had cancer within the last five years are also not eligible.
Because infliximab temporarily calms the immune system, people with active infections, a history of tuberculosis (TB), hepatitis, or HIV cannot join. You also cannot take part if you already take certain immune-suppressing medicines or if you have had a live vaccine in the four weeks before your injury.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 60 or over.
- I have broken my hip and need an operation to fix it.
- I do not have severe kidney, liver, or heart disease.
- I do not have a current infection or a history of tuberculosis (TB), hepatitis, or HIV.
- I do not have multiple sclerosis or a history of cancer in the past 5 years.
- I do not currently take biologic or anti-inflammatory immune medicines.
What does participation involve?
If you take part, your normal hospital care will not be delayed. During your hip operation, you will receive either infliximab or a dummy liquid (placebo) through a standard drip into a vein. Half of the patients get the medicine and half get the placebo. A computer chooses this at random, and neither you nor your doctors will know which one you received to keep the test fair.
Over the first five days after your surgery, a researcher will visit you on the ward to ask a few short, simple questions to check your memory and concentration. In some hospitals, participants may also be asked if they agree to have quick blood tests or simple brain-wave monitoring during surgery.
After you go home, the research team will keep in touch by phone or post at regular points over 12 months. They will ask simple questions about your walking, general health, and day-to-day quality of life.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
Will taking part delay my hip operation?
No. Your surgery will take place at the normal scheduled time. The study medicine or placebo is simply given through your drip during the planned operation.
Will I or my family know if I received infliximab?
No. To keep the study fair and unbiased, neither you, your relatives, nor your hospital care team will know whether you received infliximab or the dummy liquid.
Is infliximab a brand-new experimental drug?
No. Infliximab has been safely used across the NHS for many years to treat inflammatory diseases. This study is testing whether using it during surgery helps prevent brain confusion.
What happens if I am too tired or unwell to answer questions after surgery?
The checks are very short and gentle. If you are resting, unwell, or unable to answer, the research team can speak with a close family member or check your hospital notes instead.
Can I leave the study if I change my mind later?
Yes. You or your family can decide to stop taking part at any time. You do not need to give a reason, and your medical care will continue as normal.
How to find out more
Matthew Costa
Always speak to your GP or specialist before deciding to take part in a study.
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