Official Title: “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"”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: April 2010

Intervention(s) in this Clinical Trial

• Other: HES (130/0.4)
  • 33 ml/kg i.v. during surgery
• Other: Ringer's Lactate
  • 33 ml/kg i.v.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: HES (130/0.4)
  • 33 ml/kg i.v. HES (130/0.4)
• Placebo Comparator: Ringer's Lactate
  • 33 ml/kg i.v. Rigner's Lactate

Primary Measures

• 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
    Safety Issue?: Yes

Secondary Measures

• Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
  • Time Frame: first 24 postoperative hours
    Safety Issue?: Yes
• Re-exploration for bleeding
  • Time Frame: first 24 postoperative hours
    Safety Issue?: Yes
• Total intravenous volume administration required in OR and during first 24 hours post-op hours.
  • Time Frame: first 24 postoperative hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: St. Boniface General Hospital Research Centre

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00801190

Study ID Number: HES

ClinicalTrials.gov Identifier: NCT00801190

Health Authority: Canada: Ethics Review Committee