A Phase IV, Unicenter, Randomized, Double-Blind, Parallel-Group, Comparaty Study of Intravenous and Oral Iron vs Placebo in Patient Under Extracorporeal Circulation in Cardiovascular Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Haemoglobin and Hematocrit values
研究概览
简要总结
Anaemia is a common postoperative problem of cardiovascular surgery after cardiopulmonary bypass (CPB). Because of this the need for hemoderived blood transfusions is high. The purpose of this study was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact of the iron on the transfusion rate in postoperative cardiovascular surgery under extracorporeal circulation.
详细描述
Prospective double dummy triple blind study of 159 patients undergoing CPB; randomised in 3 groups treated with iron intravenously (iv) (group I), with iron orally (group II) controlled with placebo (group III). Patients from group I were treated with iv Iron sucrose , three doses of 100 mg of iv iron every 24 hours during postoperative hospitalization and 1 pill/24 h of oral placebo during the first month after discharge. Group II was programmed to receive 1 iron pill orally every 24 hours pre and postoperatively and up to one month after discharge and a placebo while hospitalized. Group III was programmed to receive an oral and iv placebo pre and postoperatively.
Variables were collected preoperatively, at operation room and at Intensive Care Unit admission and discharge, at postoperative floor discharge and at one month after surgical discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age
- •Patients subject to elective cardiac surgery under extracorporeal circulation
- •Patients without previous anaemia, susceptible of treatment
- •Patients without need of blood transfusion preoperative
- •Patients providing written informed consent
- •Patients who are able to complete all study visits per protocol
排除标准
- •Patients subject to elective cardiac surgery, but without extracorporeal circulation
- •Patients who were treated with fibrinolytic therapy 48 hours before the surgery
- •Patients with history of impaired renal function, (e.g., calculated creatinine clearance <50 mL/min/1.73 m2)
- •Patients operated of active endocarditis
- •Redo-surgery patients
- •Women who are pregnant or lactating
- •Patients with clinical of digestive bleeding
- •Patients with vitamin B12 deficit
- •Patients with ferropenic anaemia
- •Patients with clinical history of asthma or allergy
- •Patients with active infection
- •Patients who are included in another clinical study
- •Patients with hepatic disease
- •Patients with history of allergy to iron
- •Patients unlikely to adhere to protocol follow-up
研究组 & 干预措施
IV trivalent saccharose hydroxide ferrous
干预措施: IV trivalent saccharose hydroxide ferrous (Drug)
Oral ferrous fumarate
干预措施: Oral ferrous fumarate (Drug)
Oral and intravenous Placebo
干预措施: Oral and intravenous Placebo (Drug)
结局指标
主要结局
Haemoglobin and Hematocrit values
时间窗: 2 years
The objective was to compare the clinical efficacy of intravenous and oral iron in anaemia and the impact on the transfusion rate needing in Cardiovascular surgery under cardiopulmonary bypass
次要结局
- need for hemoderived blood transfusions, postoperative stay and hospital costs(2 years)