Efficacy of Ferric Carboxymaltose (Ferinject®) in Anemic Patients Anticipating Pancreatoduodenectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Perioperative transfusion rate
研究概览
简要总结
This phase II study is to evaluate the safety and efficacy of Ferinject® in reducing perioperative transfusion in iron deficiency anemia patients anticipating pancreatoduodenectomy.
详细描述
Primary objectives : Perioperative transfusion rate (including preop, intraop, postop≦7 days).
Secondary objectives : Postoperative complication, hospital stay, change of hematological parameters (Hb, ferritin, transferrin saturation (TSAT) change after Ferinject® injection), adverse effect with Ferinject® injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥19 years old
- •anticipating PD
- •preoperative Hb of Female 7.0-11.9g/dl and Male 7.0-12.9g/dl
- •signed written informed consent
排除标准
- •a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
- •hypersensitivity to any component of the formulation
- •active severe infection/inflammation
- •history of transfusion, erythropoietin, >500 mg intravenous iron administration within 4 weeks prior to screening.
- •history of acquired iron overload.
- •MCV > 95µm3 or TSAT > 35%
- •patients with preoperative Hb<7 g/dl
- •pregnancy or lactation
- •decreased renal function (defined as creatinine clearance <50 L/min/1.73m2calculated by eGFR(MDRD))
- •chronic liver disease or increase of liver enzymes (ALT, AST) >5 times the upper limit of normal range
研究组 & 干预措施
Ferinject
Ferinject to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg .
Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® must be diluted only in sterile 0.9% sodium chloride.
Strength/Packaging: 10 mL vials containing 500 mg iron as iron per vial.
干预措施: Ferinject (Ferric Carboxymaltose) (Drug)
结局指标
主要结局
Perioperative transfusion rate
时间窗: from preoperative baseline within the first 7 days after surgery
To evaluate reducing transfusion rate during perioperative period
次要结局
- Adverse event(up to 4-6 weeks after surgery)
- Assessment of complications after surgery as assessed by Clavien-Dindo classification of surgical complications(up to 4-6 weeks after surgery)
- Change of hematology parameters(up to 4-6 weeks after surgery)
研究者
Sang-Jae Park
Head of Center for Liver Cancer, Chief of the Liver and Pancreatobiliary Cancer Branch
National Cancer Center, Korea