The Effect of Intra Venus Ferric Carboxymaltose Preoperative on Hemoglobin and Blood Transfusion Post Cardiac Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 主要终点
- In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl%
研究概览
简要总结
Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion.
There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.
详细描述
Research Objectives
The study objectives are:
- Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery.
- Determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation.
Research Methods Prospective, randomized, double-blind, placebo-controlled research. All patients who are in the cardiac surgery department for bypass surgery, valve replacement surgery or combined surgery will be eligible to participate in the study. The study will be presented and explained to all patients and, if they consent, patients will be divided into two random groups. One group will receive Ferinject IV 24-48 hours prior to surgery. The second group will receive a placebo drug in the same time period as when the drug Ferinject is administered.
The Population Studied All patients aged 18 or older hospitalized at the Rambam Medical Center and are candidates for open-heart surgery (coronary artery bypass, valve, combined).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
- •Hemoglobin above 12g/dL in women and above than 13g\dL in men.
排除标准
- •Patients who require emergency heart surgery.
- •Patients who are not hemodynamically stable or intubated pre-operatively.
- •Patients with a known sensitivity to iron.
- •Patients with a known history of allergies (rashes, etc.).
- •Patients with liver failure (alanine aminotransferase> 3 times normal).
- •Patients with cirrhosis.
- •Patients with an active infection.
- •Patients with rheumatoid arthritis and indications of an active infection.
- •Pregnant women.
- •Lactating women.
- •Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
- •Patients participating in another drug trial.
- •Patients treated with iron who took medication within the four weeks prior to surgery.
- •Patients who received a blood transfusion in the four weeks prior to surgery.
研究组 & 干预措施
ferinject
-Patients will receive 1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
干预措施: Ferinject (Drug)
placebo
Patients will receive a placebo drug intravenous approximately 24 hours before surgery
干预措施: Placebo (Drug)
结局指标
主要结局
In order to determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation, we will count the number of red packed cells and hemoglobin will be measured in gr\dl%
时间窗: 2 years
• All patients post heart surgery will be admitted to the intensive care unit cardiac surgery for a minimum of 48 hours. The unit has regular and routine monitoring for blood tests (blood chemistry panel, coagulation) and blood gases.
次要结局
未报告次要终点
研究者
Gil Bolotin MD
prof
Rambam Health Care Campus