A Prospective Randomized Double-Blind Placebo-Controlled Trial of the Effects of Colloid (HES 130/0.4) Versus Crystalloid (Ringer's Lactate) on Bleeding in Patients Undergoing Cardiopulmonary Bypass for Primary CABG, Single Valve Repair/Replacement, or Combined Single Valve/CABG Surgery"
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 主要终点
- To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB).
研究概览
简要总结
The overall aim of this study is to determine if there is a bleeding risk associated with the use of starch-containing fluids during cardiac surgery. The specific purpose of this study will be to examine, in a prospective randomized double-blind placebo-controlled fashion, the effects of colloid (HES 130/0.4) vs. crystalloid (Ringer's Lactate) on bleeding in patients undergoing cardiopulmonary bypass for cardiac surgery. The primary end point of this trial will be chest tube output at 24 hours. In addition, a range of secondary end points focusing on transfusion parameters, as well as other important end-organ outcomes, will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 - 85 years of age, inclusive
- •Willing and able to provide informed consent
- •Elective primary coronary artery bypass graft (CABG) requiring cardiopulmonary bypass, isolated valve repair, or isolated valve replacement surgery, or combined single valve plus CABG.
排除标准
- •Emergency surgery (< 12 hours from determination of need for surgery)
- •Significant other concomitant surgery (including, but not limited to, multiple valve replacement, CEA, planned circulatory arrest, etc.)
- •LVEF < 25 %
- •Preoperative use of inotropes
- •Preoperative intraoartic balloon pump (IABP)
- •Renal dysfunction: Serum Creatinine >140 μmol/L
- •Hepatic dysfunction: AST or ALT > 2.5 x upper limit normal; or otherwise known hepatic disease
- •Preoperative Hb < 100 g/L
- •Platelet count <100,000/mm3,
- •INR > 1.3; PTT > 38 sec (with the exception of patients receiving preoperative heparin)
- •History or family history of bleeding disorder
- •Patients currently receiving: Eptifibatide (Integrilin) within 12 hours Danaparoid, Enoxaparin sodium (Lovenox) or other low molecular weight heparin within 24 hours ,Clopidogrel (Plavix) within 7 days ,Warfarin (Coumadin) within 5 days, Ticlopidine (Ticlid) within 7 day
- •Dermatological syndromes with pruritus
- •Planned neuraxial anesthetic technique
- •Receipt of an investigational drug or device, within 30 days prior to study treatment
- •Pregnant or breast feeding females
结局指标
主要结局
To assess the effect of colloid (HES 130/0.4) administration on blood loss (as determined by chest tube drainage in the first 24 postoperative hours) in patients undergoing cardiac surgery utilizing cardiopulmonary bypass (CPB).
时间窗: first 24 postoperative hours
次要结局
- Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization(first 24 postoperative hours)
- Re-exploration for bleeding(first 24 postoperative hours)
- Total intravenous volume administration required in OR and during first 24 hours post-op hours.(first 24 postoperative hours)