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 operatio

Not Applicable

• Conditions: Hip fracture; Musculoskeletal Diseases

• Registration Number: ISRCTN28447330
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-20
• Last Update Posted: 4 March 2024
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

Adults aged 60 years or over diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment

Exclusion Criteria

1. The patient has severely impaired renal function eGFR <30 ml.min-1
2. The patient has severely impaired hepatic function
3. The patient is currently taking any anti-TNF drug
4. The patient has a contra-indication to anti-TNF injection
5. The patient has a known hypersensitivity to any anti-TNF agent or any of the excipients
6. The patient has known active tuberculosis (TB) or a history of TB or is at risk of developing TB e.g. through the use of immunosuppressants
7. The patient has another known active infection (chronic or localised) or known history of recurring infections or conditions which may predispose patients to infection, including the use of concomitant immunosuppressive medications
8. The patient has known lung fibrosis
9. The patient had systemic inflammatory disorder such as rheumatoid arthritis or inflammatory bowel disease
10. The patient has known moderate to severe heart failure (NYHA class III/IV)
11. The patient has HIV, Hepatitis B or C (based on medical history)
12. The patient is at risk of Hepatitis B or HIV infections, including intravenous drug use
13. The patient has been diagnosed with Multiple Sclerosis (MS) or other central or peripheral nervous system demyelinating disorders
14. The patient has ever been diagnosed with cancer or current suspected cancer, except basal cell carcinoma (BCC/rodent ulcer)
15. The patient has had a live vaccination 4 weeks prior to study entry or will require one within 12 weeks after the study intervention
16. 16. The patient takes biologics including anakinra or abatacept or DMARDS.
17. The patient is or has been a participant in a clinical trial of a medicinal product in the last 12 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak postoperative delirium measured using the Memorial Delirium Assessment Scale (MDAS) on days 1-5 after surgery

Secondary Outcome Measures

Name	Time	Method
1. Cognitive impairment measured using the Telephone Interview for Cognitive Status (TICS) at 4 and 12 months post-diagnosis of a hip fracture<br>2. Health-related quality of life measured using the Euroqol-5D-5L pre-injury, at 4 and 12 months post-diagnosis of a hip fracture<br>3. Mortality risk measured using death notification up to 12 months post-diagnosis of a hip fracture<br>4. Subjective mobility status measured using the UK National Hip Fracture Database Mobility Scale at 4 and 12 months post-diagnosis of a hip fracture<br>5. Residential status measured using the UK National Hip Fracture Database Residential Status at 4 and 12 months post-diagnosis of a hip fracture<br>6. Risk and pattern of complications measured using bespoke reporting forms up to 12 months post-diagnosis of a hip fracture