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临床试验/NCT01705470
NCT01705470撤回不适用

Furosemide Treatment Before Blood Transfusion in Patients With Systolic Dysfunction

Tel-Aviv Sourasky Medical Center0 个研究点开始时间: 2012年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment

研究概览

简要总结

The study Objective is to assess the clinical and echocardiographic changes of patients with systolic dysfunction receiving blood transfusion, with or without prior treatment with furosemide

详细描述

More than 4 million patients receive a blood transfusion each year in the United States, many of them suffer from congestive heart failure. The reported prevalence of anemia in CHF is unknown, ranges widely from 4% to 70%, due to a lack of an established, consistent definition of anemia in CHF.

Treating CHF patients with furosemide prior to blood transfusion became a common practice, even though no randomize clinical trial had examine this issue. Nand et al. measured the pulmonary capillary wedge pressures in 20 adults with chronic severe anemia (Hg <6 mg/dl) and no systemic disease before and after transfusion of 700ml of whole blood. Ten of these patients were treated with furosemide (40 mg intra-venous) immediately prior the transfusion. The PCWP had increased significantly among patient who did not receive the furosemide and decreased by 3.75% among patients in the furosemide group, although this change was not was statistically significant. In another study, the same group of Nand et al. measured the PCWP among 40 chronic anemia patients receiving blood transfusion. None of the patients suffered from cardiopulmonary disease. The patients were randomly divided into 4 groups: the difference between the first 3 groups was the speed of the transfusion (2 ml/min, 5 ml/min and 10 ml/min). The fourth group patients were treated with 40 mg of furosemide before the transfusion was given in a rate of 5 ml/min. The PCWP increased significantly in the first 3 groups, with the rise being proportionately greater with faster transfusions (15.8, 20.9 and 32.2% in groups A, B and C, respectively). In the furosemide group, however, the PCWP decreased significantly by 21.7%.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • Subject is over 18 years old.
  • Documented ejection function equal to or over 40% in prior tests
  • The treating physician decided to treat the patient with packed cell

排除标准

  • Known hypersensitivity to furosemide.
  • Calculated creatinine clearance over 20% (by MDRD)
  • Past adverse reaction to blood product.

研究组 & 干预措施

arm1

Experimental

will receive 60 mg (6 ml) of intra-venous furosemide before administration of the blood transfusion (250-300 ml of packed cells).

干预措施: furosemide (Drug)

arm2

Experimental

will receive 6 ml of normal saline (NaCl 0.9%) before administration of the blood transfusion (250-300 ml of packed cells).

干预措施: placebo normal saline (Drug)

结局指标

主要结局

Diastolic echocardiographic changes following blood transfusion, with or without Furosemide treatment

时间窗: Within 4 hours from receiving the blood transfusion

Diastolic echocardiographic variables, including Ea, E to Ea ratio, E to A ratio, and Pulmonary vein flow velocities, following blood transfusion, with or without Furosemide treatment

次要结局

  • clinical outcome following blood transfusion, with or without Furosemide treatment(Within 4 hours from receiving the blood transfusion)

研究者

申办方类型
Other Gov
责任方
Sponsor

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