ISRCTN28447330进行中（未招募）Unknown
A feasibility study for a randomised controlled comparison on the effect of infusion of anti-TNF or placebo during surgery on delirium symptoms between hip fracture patients over 60 years of age
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Adults aged 60 years or over diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment
排除标准
- •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
研究者
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