Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
NCT00646373 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2011-04-20
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.
Conditions
- Cardiac Surgery
Interventions
- OTHER
-
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.
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-12-31
- Primary Completion
- 2006-12-31
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