An Intravenous Iron Based Protocol for Optimizing Haemoglobin in Anaemic Patients Prior to Fast-track Hip and Knee Arthroplasty - An Observational Follow up Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Transfusion Rate
研究概览
简要总结
This observational study follows a cohort of patients scheduled for elective hip- or knee surgery but has preoperative anemia and are treated with Intravenous (IV) iron prior to surgery according to a recently introduced standardized treatment protocol at 6 high-volume surgical centres.
详细描述
Patients presenting with preoperative anaemia prior to hip and knee arthroplasty has a high risk of receiving allogeneic blood transfusion and anaemia has been associated with increased postoperative morbidity and mortality. While IV-iron administration may raise Hb prior to surgery, existing guidelines for addressing and treating preoperative anaemia is not widely implemented for patients scheduled for elective total joint arthroplasty (TJA) in Denmark. In addition, causes of preoperative anaemia and the efficacy of preoperative IV-iron administration has not been sufficiently evaluated in elective TJA.
This is a observational follow-up study among 6 Danish high volume surgical centres that has recently introduced a standardized anaemia screening and treatment protocol for patients with preoperative anaemia scheduled for total hip- or knee arthroplasty.
Patients with iron deficiency anaemia or anaemia of chronic inflammation receive infusion of IV-iron (Monofer) 4 weeks prior to surgery as a part of the standard operating procedure on the department.
The aim of this follow up study is to evaluate changes in Haemoglobin concentration, transfusion rate and postoperative morbidity in this cohort.
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
- •Scheduled for elective primary hip- or knee arthroplasty
- •Preoperative hemoglobin < 13 g/dl (males) or < 12 g/dl (females)
- •Included in the departments treatment protocol for preoperative anemia
排除标准
- •Cronic transfusion need
- •Not able to give consent
研究组 & 干预措施
Patients with preoperative anemia following treatment protocol
Patients with preoperative anemia according to the WHO definition and treated with a protocol of Iitravenous iron prior to surgery
干预措施: Iron-III Isomaltoside 1000 (Drug)
Patients with preoperative anemia - Historical control
Cohort of preoperative anemic patients from the Lundbeckcentre Database. Serving as a historical control
干预措施: Standard Care (Other)
结局指标
主要结局
Transfusion Rate
时间窗: From date of admission to date of discharge (up to 30 days)
Blood transfusion (yes/no) during the entire hospital stay
次要结局
- Classification of preoperative anemia(4 weeks prior to surgery (baseline))
- Change in hemoglobin concentration(From date of preoperative blood sampling (baseline) to date of admission (Up to 4 weeks))
- No. of red blood cell units administered per patient(From date of admission to date of discharge (up to 30 days))
- Length of Hospital stay(From date of admission to Date of discharge (up to 30 days))
- Postoperative complications and readmissions(From date of surgery up to 90 days after surgery)
研究者
Oeivind Jans
M.D., Ph.D.
Rigshospitalet, Denmark