Efficacy of a Preoperative Anaemia Clinic in Patients Undergoing Elective Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 764
- 试验地点
- 1
- 主要终点
- Assess the possible change in hemoglobin (Hb) concentration in patients with iron deficiency anaemia undergoing intravenous iron infusion of MonoFer prior to abdominal surgery.
研究概览
简要总结
Efficacy of a preoperative anaemia clinic in patients undergoing elective abdominal surgery diagnosed with iron deficieny anaemia
详细描述
Objective
this study aims to investigate how preoperative intravenous iron treatment affects hemoglobin elevations in patients undergoing elective abdominal surgery diagnosed with iron deficiency anaemia and when treatment should be administrated for optimal effect.
Methods: the study is a prospective, descriptive cohort study, where patients are included from a quality improvement project at The Departments of Abdominal Surgery and the Department of Anesthesia, Centre for Cancer and Organ Disease at Rigshospitalet in Denmark. Patients undergoing elective abdominal surgery will be screened for iron deficiency anaemia 1-4 weeks prior to surgery and patients diagnosed with iron deficiency anaemia will be included. Intravenous iron infusion will be administrated preoperatively and Hb will be measured 1-2 days prior to surgery or on day of surgery. The preparation used is ferric derisomaltose (MonoFer, Pharmacosmos A/S, Holbæk, Denmark) with a max single iron dose of 20 mg/kg. The dose administrated is calculated using patient bodyweight and Hb value and administered ≥30 minutes followed by 30 minutes observation including monitoring with 3-lead ECG and pulsoximitri.
Study results will be sought to be published in an international peer-reviewed journal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with preoperative iron deficiency anaemia
- •All patients receiving preoperative or postoperative intravenous iron infusion
- •Patients undergoing elective abdominal surgery
排除标准
- •Patients missing Hb values after intravenous iron infusion prior to surgery
- •Patients undergoing acute abdominal surgery
结局指标
主要结局
Assess the possible change in hemoglobin (Hb) concentration in patients with iron deficiency anaemia undergoing intravenous iron infusion of MonoFer prior to abdominal surgery.
时间窗: Hb values [mM] from blood samples taken before the preliminary examination and 1-2 days prior to surgery in patients receiving intravenous iron infusion
Preoperative anaemia is defined as: * Hb \<8,1 mM for men * Hb \<7,5 mM for women Iron deficiency was defined as TSAT \<20%. Iron deficiency anaemia was defined as TSAT \<20% with concurrent anaemia. Paired Student's t-test will be performed to analyze whether intravenous iron infusion prior to surgery results in a significant increased Hb level at the day of surgery in patients with preoperative iron deficiency anaemia. In case data is not normally distributed, data will be analyzed using Wilcoxon signed rank test.
次要结局
- Assess the ideal time point for administration of preoperative intravenous iron infusion of MonoFer and the effect on Hb concentration(Hb values [mM] from blood samples taken before the preliminary examination and 1-2 days prior to surgery in patients receiving intravenous iron infusion. Number of days between infusion of intravenous MonoFer and day of surgery (up to 3 months)).)
研究者
Eske Kvanner Aasvang
Clinical Professor
Rigshospitalet, Denmark