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"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bloodloss
- Sponsor
- St. Boniface Hospital
- Enrollment
- 500
- Primary Endpoint
- 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).
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
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).
Time Frame: first 24 postoperative hours
Secondary Outcomes
- 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)