This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bloodloss

Intervention / Treatment
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* Other: HES (130/0.4)
* Other: Ringer's Lactate


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HES (130/0.4)<br>33 ml/kg i.v. HES (130/0.4) | Other: HES (130/0.4)<br>* 33 ml/kg i.v. during surgery<br>* Other names: Voluven;|
| Placebo Comparator: Ringer's Lactate<br>33 ml/kg i.v. Rigner's Lactate | Other: Ringer's Lactate<br>* 33 ml/kg i.v.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colloid, CABG, cardiopulmonary bypass, bleeding