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Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures

Primary Purpose

Cardiac Surgery

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Low Prime
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Surgery focused on measuring Cardiac surgery, Pump prime, Blood transfusions

Eligibility Criteria

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

Inclusion Criteria:

  • >18 y of age
  • Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG)
  • Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation)

Exclusion Criteria:

  • aPTT >50 s, INR>1.5
  • Plt < 100,000 x 106
  • Preoperative Hemodialysis
  • Tight aortic stenosis (Aortic Valve Area < 1 cm2)
  • Tight lesion of the left main coronary artery (> 60%)
  • Use of Aprotinin requested by the Surgical Team

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The number of units of blood products transfused within the first 24 hours post CPB.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 25, 2008
    Last Updated
    April 19, 2011
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00646373
    Brief Title
    Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
    Official Title
    Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2006
    Overall Recruitment Status
    Terminated
    Why Stopped
    Protocol was comparing to standard of practice, which has changed over the course of slow recruitment and no longer can be used as a comparator.
    Study Start Date
    December 2006 (undefined)
    Primary Completion Date
    December 2006 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    5. Study Description

    Brief Summary
    The objective of this study is to evaluate the impact of reduced pump prime on blood transfusions and postoperative complications in patients at high risk of severe hemodilution during CPB. HYPOTHESIS The use of a new CPB circuit with a smaller internal volume, together with retrograde autologous priming of the lines (RAP) will allow a smaller prime volume and therefore less significant hemodilution on pump. EXPERIMENTAL DESIGN Overview Patients will be randomized on the morning of surgery to one of the two study groups in a 1:1 allocation scheme: Low pump prime Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Surgery
    Keywords
    Cardiac surgery, Pump prime, Blood transfusions

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    Low Prime
    Intervention Description
    The CPB circuit will be primed with mannitol (50 g of 20% solution) and crystalloid solution (Ringer's lactate) for a total volume of approximately 1200 ml.
    Primary Outcome Measure Information:
    Title
    The number of units of blood products transfused within the first 24 hours post CPB.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: >18 y of age Non-emergent complex cardiac surgery (any procedure other than primary isolated CABG) Any of the following: Hb < 120 g/L (Females) or < 130 g/L (Males)BSA < 1.6 m2Creatinine Clearance < 60 mL/min (Cockcroft Gault Equation) Exclusion Criteria: aPTT >50 s, INR>1.5 Plt < 100,000 x 106 Preoperative Hemodialysis Tight aortic stenosis (Aortic Valve Area < 1 cm2) Tight lesion of the left main coronary artery (> 60%) Use of Aprotinin requested by the Surgical Team

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures

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