CompletedPhase 2Phase 3ACTRN12605000214639

Reducing brain injury in cardiac surgery

Dual vent circuit cardiopulmonary bypass to reduce ischemic brain injury in cardiac surgery.


Sponsor

Auckland City Hospital

Enrollment

144 participants

Start Date

Jul 4, 2004

Study Type

Interventional

Conditions

Summary

The primary purpose of the study is to investigate whether a newly developed cardiopulmonary (heart) bypass technique, reduces brain injury as a complication of the surgery, compared with conventional cardiopulmonary bypass techniques.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • Able to give informed consent; neurologically independent; requiring elective cardiac valve replacement or repair in the left heart; able to undergo magnetic resonance imaging.

Exclusion Criteria1

  • Concomitant medical conditions making followup over 6 weeks unlikely; hemodynamically unstable; frequent cardiac arrhythmias; mobile atherosclerotic plaque in the aortic arch; overt congestive heart failure.

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Interventions

Randomised controlled participant and assessor blinded study of an investigational dual vent circuit cardiopulmonary bypass technique in elective open heart surgery patients. Pre-operative and up to 6

Randomised controlled participant and assessor blinded study of an investigational dual vent circuit cardiopulmonary bypass technique in elective open heart surgery patients. Pre-operative and up to 6 weeks post-operative clinical assessments and magnetic resonance imaging studies performed.


Locations(1)

New Zealand

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ACTRN12605000214639