Effect of Decreased Pump Prime Volume on Blood Transfusions and Postoperative Complications of Patients Undergoing High Risk Cardiac Surgical Procedures
|ClinicalTrials.gov Identifier: NCT00646373|
Recruitment Status : Terminated (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.)
First Posted : March 28, 2008
Last Update Posted : April 20, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Surgery||Other: Low Prime||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||December 2006|
|Actual Primary Completion Date :||December 2006|
Other: Low Prime
- The number of units of blood products transfused within the first 24 hours post CPB. [ Time Frame: 24 hours ]