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临床试验/NCT02969811
NCT02969811Unknown不适用

Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study Study Protocol: Cardiac Injury and Anaemia Following Surgery for Fractured Neck of Femur: An Observational Study

NHS Lothian0 个研究点目标入组 200 人开始时间: 2016年12月最近更新:
适应症

试验速览

阶段
不适用
发起方
NHS Lothian
入组人数
200
主要终点
Cardiac Injury

研究概览

简要总结

Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

  1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
  2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
  3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

详细描述

Blood transfusion is an expensive and finite resource and optimum transfusion threshold in surgical patients is yet to be defined. Patients commonly receive blood transfusions to reduce the risk of myocardial ischaemia or improve perfusion of other organs (e.g. the kidneys), but this treatment may have important adverse effects including postoperative infection. There is great interest in restrictive transfusion practices (e.g. a transfusion trigger of 70 g L-1), however patients with co-existing cardiovascular disease have been excluded from studies of restrictive versus liberal transfusion strategies. Highly sensitive troponin assays are now available, which allow clinicians to reliably detect cardiac injury in increased numbers of patients who have undergone major surgery. Troponin release after surgery is common, as high as 40% in some studies. Patients undergoing surgery for fractured neck of femur are often elderly, with co-morbidities and a high risk of postoperative complications, including MI and AKI. We propose to conduct a study with the following aims:

  1. To describe the incidence of anaemia and transfusion in patients undergoing surgery for fractured neck of femur.
  2. To use clinical and biochemical data to measure the incidence of perioperative cardiac and kidney injury in this group.
  3. To evaluate highly sensitive serum troponin and urinary MALDI-MS as possible endpoints in a future prospective randomised trial of perioperative transfusion.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fractured Neck of Femur
  • Informed consent

排除标准

  • refusal of consent

结局指标

主要结局

Cardiac Injury

时间窗: 72 hours after surgery

Serum Troponin above upper reference limit

次要结局

未报告次要终点

研究者

发起方
NHS Lothian
申办方类型
Other Gov
责任方
Sponsor

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