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

Not Applicable
Terminated
Conditions
Cardiac Surgery
Registration Number
NCT00646373
Lead Sponsor
University Health Network, Toronto
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:

1. Low pump prime

2. Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
50
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)
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The number of units of blood products transfused within the first 24 hours post CPB.24 hours
Secondary Outcome Measures
NameTimeMethod
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