Preoperative Anaemia Prevalence in Surgical Patients- A Prospective, International, Multicentre Observational Study (ALICE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Prevalence of preoperative anaemia
研究概览
简要总结
Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality.
Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery.
详细描述
Preoperative anaemia is common in surgery, with a prevalence between 10 and 50 %, and is an independent risk factor for morbidity and mortality. Due to the potential risk of additional blood loss, anaemia represents a serious disease condition within the surgical field. Especially patients undergoing major elective surgery are at risk of substantial blood loss. Anaemia is mostly the result of an inadequate erythropoiesis due to iron deficiency, lack of vitamin B12 or folate, and bone marrow diseases. Among the elderly, renal disease and chronic inflammation account for approximately one-third of all anaemia incidences. The aim of this study is to provide detailed data about the prevalence of preoperative deficiencies in iron, vitamin B12 and/or folate and the presence of underlying renal or chronic diseases in patients undergoing major surgery. Results will facilitate design of supplementation strategies to improve haemoglobin level before surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Written informed consent prior to study participating according to the national law requirements
- •Patients undergoing major surgery
- •Expected hospital stay with a minimum of 24 hours
排除标准
- •Preoperative autologous blood donation
- •Patients with expected re-surgery within the planned 7-day recruitment period
结局指标
主要结局
Prevalence of preoperative anaemia
时间窗: prior surgery
Hemoglobin level
次要结局
- Re-admission(up to 90 days after discharge)
- Number of patients with red blood cell transfusion(30 day)
- Number of patient with revision(90 day)
- Number of patients with mortality(90 day)
- Hospital and ICU length of stay(30 days)
- Incidence of hospital-acquired anaemia(30 days)
研究者
Dr. Patrick Meybohm, M.D.
Principal Investigator
Wuerzburg University Hospital