Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: An inception cohort study

Not Applicable

Recruiting

• Conditions: High-risk cardiac surgery; Cardiovascular - Coronary heart disease; Ischaemic heart disease; Surgery - Surgical techniques

• Registration Number: ACTRN12613000293763
• Lead Sponsor: Australia and New Zealand Cardiothoracic Surgery cardiac surgery database program

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Patients booked for coronary artery bypass graft surgery with at least two of the following characteristics
- left ventricular ejection fraction <30%
- redo cardiac surgery
- unstable angina
- left main coronary artery stenosis > 50%

Exclusion Criteria

Age < 18 years
The patients has a left ventricular assist device in situ prior to planned surgery

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality at 6 months post surgery[6 months post surgery]

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by the EQ5D[6 months post surgery];adverse events attributable to intra-aortic balloon counterpulsation including local complications, ischaemia to the limb, bleeding, infection and haemolysis[Monitored in a daily basis during the hospital stay];mortality within 30 days of surgery[Within 30 days of surgery];Composite of mortality, stroke, acute kidney injury and acute myocardial infarction. Stroke will be assessed on clinical grounds, acute kidney injury will be assessed on biochemical grounds and requirement for dialysis and acute myocardial infarction will be assessed using troponin measurements.[Monitored throughout the post operative hospital stay]