search
Back to results

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

Primary Purpose

Bloodloss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HES (130/0.4)
Ringer's Lactate
Sponsored by
St. Boniface Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bloodloss focused on measuring colloid, CABG, cardiopulmonary bypass, bleeding

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    HES (130/0.4)

    Ringer's Lactate

    Arm Description

    33 ml/kg i.v. HES (130/0.4)

    33 ml/kg i.v. Rigner's Lactate

    Outcomes

    Primary Outcome 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).

    Secondary Outcome Measures

    Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
    Re-exploration for bleeding
    Total intravenous volume administration required in OR and during first 24 hours post-op hours.

    Full Information

    First Posted
    December 2, 2008
    Last Updated
    December 2, 2008
    Sponsor
    St. Boniface Hospital
    Collaborators
    University of Manitoba
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00801190
    Brief Title
    This Study Will Compare the Effect of Starch Containing to Non-Starch Containing Intravenous Fluid on Blood Loss During Coronary Artery Bypass Graft Surgery
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    April 2010 (Anticipated)
    Study Completion Date
    April 2011 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    St. Boniface Hospital
    Collaborators
    University of Manitoba

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bloodloss
    Keywords
    colloid, CABG, cardiopulmonary bypass, bleeding

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HES (130/0.4)
    Arm Type
    Active Comparator
    Arm Description
    33 ml/kg i.v. HES (130/0.4)
    Arm Title
    Ringer's Lactate
    Arm Type
    Placebo Comparator
    Arm Description
    33 ml/kg i.v. Rigner's Lactate
    Intervention Type
    Other
    Intervention Name(s)
    HES (130/0.4)
    Other Intervention Name(s)
    Voluven
    Intervention Description
    33 ml/kg i.v. during surgery
    Intervention Type
    Other
    Intervention Name(s)
    Ringer's Lactate
    Intervention Description
    33 ml/kg i.v.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    Transfusion requirements (RBC and other blood products) both at 24 hours and for duration of hospitalization
    Time Frame
    first 24 postoperative hours
    Title
    Re-exploration for bleeding
    Time Frame
    first 24 postoperative hours
    Title
    Total intravenous volume administration required in OR and during first 24 hours post-op hours.
    Time Frame
    first 24 postoperative hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs