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

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00646373
• Other study ID #: UHN REB#06-0012-B
• Status: Terminated
• Phase: N/A
• First received: March 25, 2008
• Last updated: April 19, 2011
• Start date: December 2006

Study information

• Verified date: December 2006
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: University Health Network, Ethics Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery
• Postoperative Complications

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of units of blood products transfused within the first 24 hours post CPB.		24 hours	No