Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
- 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
- >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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The number of units of blood products transfused within the first 24 hours post CPB. 24 hours
- Secondary Outcome Measures
Name Time Method