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

University Health Network, Toronto

Status: Terminated

Conditions: Cardiac Surgery

Treatments: Other: Low Prime

Study type: Interventional

Funder types: Other

Identifiers

NCT00646373

UHN REB#06-0012-B

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind