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

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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
Bloodloss Other: HES (130/0.4) Other: Ringer's Lactate

Study Design

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

Arms and Interventions

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.


Outcome Measures

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 ]

Eligibility Criteria

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
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)
  • 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
More Information

Responsible Party: Dr. Hilary Grocott, Saint Boniface general Hospital /Universit of Manitoba
ClinicalTrials.gov 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:
colloid
CABG
cardiopulmonary bypass
bleeding