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

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 Overview

• Status: Unknown
• Conditions: Bloodloss
• Intervention / Treatment: Other: HES (130/0.4); Other: Ringer's Lactate

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HES (130/0.4); 33 ml/kg i.v. HES (130/0.4)	Other: HES (130/0.4); 33 ml/kg i.v. during surgery; Other Names: Voluven
Placebo Comparator: Ringer's Lactate; 33 ml/kg i.v. Rigner's Lactate	Other: Ringer's Lactate; 33 ml/kg i.v.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: St. Boniface Hospital
• Collaborators: University of Manitoba

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): April 1, 2011

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2008
• Last Update Submitted That Met QC Criteria: December 2, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: bleeding; CABG; cardiopulmonary bypass; colloid
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: HES