NCT00646373

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. 1.Low pump prime
  2. 2.Standard pump prime Outcomes The primary outcome is the number of units of blood products transfused within the first 24 hours post CPB.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

April 20, 2011

Status Verified

December 1, 2006

Enrollment Period

Same day

First QC Date

March 25, 2008

Last Update Submit

April 19, 2011

Conditions

Cardiac Surgery

Keywords

Cardiac surgeryPump primeBlood transfusions

Outcome Measures

Primary Outcomes (1)

  • The number of units of blood products transfused within the first 24 hours post CPB.

    24 hours

Interventions

Low PrimeOTHER

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2006

Last Updated

April 20, 2011

Record last verified: 2006-12