Reducing brain injury in cardiac surgery

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000214639

Acronym

ReBICS

Enrollment

Registered

2005-08-25

Start date

2004-07-04

Completion date

2012-01-21

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 weeks post-operative clinical assessments and magnetic resonance imaging studies performed.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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.

Outcome results