A Randomized, Prospective, Blinded Clinical Trial to Evaluate the Efficacy and Safety of Pentastarch Use in Patients Undergoing Coronary Artery Bypass Surgery or Valve Replacement Surgery Using Cardiopulmonary Bypass Circuits
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- transfusion requirements
研究概览
简要总结
Patients undergoing cardiac surgery with cardiopulmonary bypass require significant fluid administration. Fluids are used routinely to replace blood lost during and after surgery. Significant amounts of fluid are also used to prime the tubing and components of the cardiopulmonary bypass pump before and during its use. The use of Pentaspan - a synthetic pentastarch - was started because of the restriction of use for blood and blood products, particularly albumin. Pentaspan is usually used after surgery in the Intensive Care Unit (ICU). The impact of the use of pentastarch on coagulation, fluid balance and bleeding are very limited. This study will methodically evaluate the impact of using increasingly greater amounts of pentastarch during surgery on an open heart surgery patient's recovery in particular - is there more bleeding, does his/her blood clot as well, and how much fluid overall is used and excreted?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing either coronary artery bypass surgery or valve surgery requiring the use of cardiopulmonary bypass circuit
排除标准
- •Emergency surgery
- •Regurgitant valve pathology
- •Redo surgery
- •Significant left ventricular (LV) dysfunction
- •Significant renal insufficiency
- •Anticipation of associated procedure - eg carotid endarterectomy
- •Ongoing sepsis or endocarditis
- •Received aspirin (ASA) or Plavix within 96 hours of surgery
结局指标
主要结局
transfusion requirements
fluid balance
次要结局
- postoperative bleeding
- coagulation parameters
- mediastinal drainage
- respiratory status
