CABG Without the Use of CPB

July 15, 2015 updated by: Melbourne Health

A Prospective Randomised Study od Coronary Artery Bypass Surgery Without the Use of Cardiopulmonary Bypass

Comparison of clinical outcomes in patients undergoing coronary bypass surgery using the heart/lung machine as opposed to using off-pump techniques.

Study Overview

Status

Completed

Conditions

Coronary Artery Bypass

Intervention / Treatment

Procedure: Coronary artery bypass

Study Type

Interventional

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria: Eligible for coronary surgery -

Exclusion Criteria: Less than 18 years Emergency and salvage operations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of clinical outcomes for coronary artery bypass graft surgery when performed using cardiopulmonary bypass versus beating heart surgery without cardiopulmonary bypass Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melbourne Health

Investigators

Study Chair: Stephen Davis, MD, Melbourne Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria