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临床试验/NCT01849757
NCT01849757撤回不适用

Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%

University of Saskatchewan2 个研究点 分布在 1 个国家开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Post-operative bleeding and transfusion requirements

研究概览

简要总结

The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery. The fluids to be compared are albumin and voluven. A control group will receive only crystalloid.

详细描述

Project title:

Comparison of priming constituents in patients undergoing CPB assisted cardiac surgery: 6% HES 130/0.4 or Albumen 5%

Principal investigator:

Jo-Anne Marcoux M. Sc., CPC, CCP

Department:

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
Single (Participant)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing cardiopulmonary bypass assisted cardiac surgery

排除标准

  • emergencies and patients in renal failure or dialysis -

研究组 & 干预措施

Voluven or hydroethylstarch HES 130/0.4

Active Comparator

Hydroethylstarch HES 130/0.4 used as part of the priming volume for the cardiopulmonary bypass circuit.

干预措施: Voluven (Other)

Crystalloid

Placebo Comparator

Crystalloid will be used to prime the cardiopulmonary bypass circuit

干预措施: prime crystalloid (Other)

Human Albumin

Active Comparator

Human albumin solution used as part of the priming volume for the cardiopulmonary bypass circuit.

干预措施: Human Albumin (Other)

结局指标

主要结局

Post-operative bleeding and transfusion requirements

时间窗: 24-48 hours post-operatively

Postoperative cardiac patients have chest tubes in place which drain any blood oozing from around the pericardial cavity. The chest tubes are attached to a blood collection apparatus which measures the amount of blood loss. Too much post-operative blood loss results in a transfusion requirement of red blood cells, plasma and/or platelets.

次要结局

  • renal function, creatinine levels(24-48 hours post-operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jo-Anne Marcoux

Perfusionist M. Sc., CPC, CCP

University of Saskatchewan

研究点 (2)

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