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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00801190
Recruitment Status : Unknown
Verified December 2008 by St. Boniface General Hospital Research Centre.
Recruitment status was:  Not yet recruiting
First Posted : December 3, 2008
Last Update Posted : December 3, 2008
University of Manitoba
Information provided by:
St. Boniface General Hospital Research Centre

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.

Condition or disease Intervention/treatment Phase
Bloodloss Other: HES (130/0.4) Other: Ringer's Lactate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
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"
Study Start Date : December 2008
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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 Name: Voluven
Placebo Comparator: Ringer's Lactate
33 ml/kg i.v. Rigner's Lactate
Other: Ringer's Lactate
33 ml/kg i.v.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization [ Time Frame: first 24 postoperative hours ]
  2. Re-exploration for bleeding [ Time Frame: first 24 postoperative hours ]
  3. Total intravenous volume administration required in OR and during first 24 hours post-op hours. [ Time Frame: first 24 postoperative hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Dr. Hilary Grocott, Saint Boniface general Hospital /Universit of Manitoba Identifier: NCT00801190     History of Changes
Other Study ID Numbers: HES
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: December 2008

Keywords provided by St. Boniface General Hospital Research Centre:
cardiopulmonary bypass