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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00646373

Enrollment

Registered

2008-03-28

Start date

2006-12-31

Completion date

Unknown

Last updated

2011-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Cardiac surgery, Pump prime, Blood transfusions

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.

Interventions

OTHERLow 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The number of units of blood products transfused within the first 24 hours post CPB.	24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026