Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
NCT ID: NCT00646373
Last Updated: 2011-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
50 participants
INTERVENTIONAL
2006-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
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Low Prime
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Toronto General Hospital
Other Identifiers
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UHN REB#06-0012-B
Identifier Type: -
Identifier Source: org_study_id
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