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

This study has been 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.)
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00646373
First received: March 25, 2008
Last updated: April 19, 2011
Last verified: December 2006
  Purpose

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 Intervention
Cardiac Surgery
Other: Low Prime

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • The number of units of blood products transfused within the first 24 hours post CPB. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Massimiliano Meineri, Toronto General Hospital
ClinicalTrials.gov Identifier: NCT00646373     History of Changes
Other Study ID Numbers: UHN REB#06-0012-B
Study First Received: March 25, 2008
Last Updated: April 19, 2011
Health Authority: Canada: University Health Network, Ethics Review Board

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014