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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

Sponsor
St. Boniface Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT00801190
Collaborator
University of Manitoba (Other)
500
Enrollment
2
Arms
28
Duration (Months)

Study Details

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 Phase
  • Other: HES (130/0.4)
  • Other: Ringer's Lactate
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2008
Anticipated Primary Completion Date :
Apr 1, 2010
Anticipated Study Completion Date :
Apr 1, 2011

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 Names:
  • 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). [first 24 postoperative hours]

    Secondary Outcome Measures

    1. Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization [first 24 postoperative hours]

    2. Re-exploration for bleeding [first 24 postoperative hours]

    3. Total intravenous volume administration required in OR and during first 24 hours post-op hours. [first 24 postoperative hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • St. Boniface Hospital
    • University of Manitoba

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00801190
    Other Study ID Numbers:
    • HES
    First Posted:
    Dec 3, 2008
    Last Update Posted:
    Dec 3, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    colloid
    CABG
    cardiopulmonary bypass
    bleeding
    Additional relevant MeSH terms:
    Hemorrhage

    Study Results

    No Results Posted as of Dec 3, 2008