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

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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
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cardiac Surgery Other: Low Prime

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Primary Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. The number of units of blood products transfused within the first 24 hours post CPB. [ Time Frame: 24 hours ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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
More Information

Responsible Party: Massimiliano Meineri, Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00646373     History of Changes
Other Study ID Numbers: UHN REB#06-0012-B
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: December 2006

Keywords provided by University Health Network, Toronto:
Cardiac surgery
Pump prime
Blood transfusions

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes