Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000293763
Ethics application status
Approved
Date submitted
13/03/2013
Date registered
15/03/2013
Date last updated
15/03/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: An inception cohort study
Scientific title
The effect of prophylactic intra-aortic balloon counterpulsation in high-risk cardaic surgery patients on mortality and quality of life at 6 months: an inception cohort study
Secondary ID [1] 282121 0
nil
Universal Trial Number (UTN)
U1111-1140-5781
Trial acronym
The PINBALL study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-risk cardiac surgery 288616 0
Ischaemic heart disease 288628 0
Condition category
Condition code
Cardiovascular 288949 288949 0 0
Coronary heart disease
Surgery 288962 288962 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study to determine the effect of prophylactic intra-aortic balloon counterpulsation on 6 month mortality and quality of life. We will observe high-risk patients undergoing coronary artery bypass graft surgery and compare patients who receive intra-aortic balloon counterpulsation prior to surgery to those who proceed to surgery without intra-aortic balloon counterpulsation.

Intra-aortic balloon counterpulsation is the process of inserting an intraaortic balloon pump, into the aorta, via the femoral artery (much like a coronary angiogram is performed), and having the balloon inflate during diastole (when the heart is relaxed), and deflate rapidly at the beginning of systole (when the heart contracts or pumps). This results in an increase in blood flow to the arteries supplying the heart muscle, and also results in a reduction in the work that heart has to do to pump blood around the body.

Intra-aortic balloon counterpulsation is commonly performed to assist cardiac function in patients with poor heart function following acute myocardial infarction or in patients with poor heart function following cardiac surgery. Prophylactic intra-aortic balloon counterpulsation is performed by commencing intra-aortic balloon counterpulsation, prior to cardiac surgery, in patients at high risk of post operative complications, in an attempt to prevent these complications post-operatively.
Intervention code [1] 286727 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289077 0
Mortality at 6 months post surgery
Timepoint [1] 289077 0
6 months post surgery
Secondary outcome [1] 301698 0
Quality of life as measured by the EQ5D
Timepoint [1] 301698 0
6 months post surgery
Secondary outcome [2] 301699 0
adverse events attributable to intra-aortic balloon counterpulsation including local complications, ischaemia to the limb, bleeding, infection and haemolysis
Timepoint [2] 301699 0
Monitored in a daily basis during the hospital stay
Secondary outcome [3] 301700 0
mortality within 30 days of surgery
Timepoint [3] 301700 0
Within 30 days of surgery
Secondary outcome [4] 301701 0
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.
Timepoint [4] 301701 0
Monitored throughout the post operative hospital stay

Eligibility
Key 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%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years
The patients has a left ventricular assist device in situ prior to planned surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/03/2013
Actual
12/03/2013
Date of last participant enrolment
Anticipated
30/09/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 748 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 749 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 750 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 751 0
The Alfred - Prahran
Recruitment postcode(s) [1] 6578 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [2] 6579 0
2065 - St Leonards
Recruitment postcode(s) [3] 6581 0
3181 - Prahran
Recruitment postcode(s) [4] 6580 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 286890 0
University
Name [1] 286890 0
Cardiothoracic reseach grant scheme
Country [1] 286890 0
Australia
Primary sponsor type
University
Name
Australia and New Zealand Cardiothoracic Surgery cardiac surgery database program
Address
CCRET, School of Public Health and Preventative Medicine
Level 6, The Alfred Centre
99 Commercial Rd
Melbourne, Vic, 3004
Country
Australia
Secondary sponsor category [1] 285678 0
None
Name [1] 285678 0
Address [1] 285678 0
Country [1] 285678 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288949 0
North shore private hospital human research ethics committee
Ethics committee address [1] 288949 0
North Shore Private Hospital
3 Westbourne St
St. Leonards, NSW, 2065
Ethics committee country [1] 288949 0
Australia
Date submitted for ethics approval [1] 288949 0
Approval date [1] 288949 0
28/02/2013
Ethics approval number [1] 288949 0
NSPHEC 2012-013

Summary
Brief summary
PINBALL Synopsis
Background
CABG surgery remains the treatment of choice for many patients with severe ischaemic heart disease, the leading cause of death in Australia and worldwide. Patients undergoing CABG surgery are increasingly older, have greater comorbidities and are at high-risk of serious adverse postoperative outcomes. Prophylactic IABC may reduce postoperative mortality and morbidity in high-risk patients however current evidence is inconclusive and use remains low.
Aim
To describe the incidence and outcomes of high-risk patients undergoing CABG surgery.
Objectives
1. Assess the crude and adjusted odds ratio for the association between prophylactic IABC and six-month postoperative mortality
2. Determine the combination of preoperative characteristics identifying a group of patients in whom prophylactic IABC may be of greatest benefit
3. Describe current perioperative management strategies of high-risk patients undergoing CABG surgery
4. Determine the quality of life at six months of high-risk patients who have undergone CABG surgery
5. Obtain information critical to the design of a RCT of prophylactic IABC in high-risk patients undergoing CABG including the calculation of sample size, determination of recruitment rates and treatment protocols for the intervention and control arms
Methods
We will conduct a prospective multi-centre inception cohort study of high-risk patients undergoing CABG surgery. All patients booked for CABG surgery with at least two of four high-risk characteristics, (left ventricular fraction less than 30%, redo cardiac surgery, left main coronary artery stenosis greater than 50% and unstable angina), will be included in the study. A telephone follow-up will be conducted at six months post surgery to measure vital status and quality of life.
Outcomes
Primary outcome:
-Six month all-cause mortality
Secondary outcomes:
- Incidence of high-risk surgery
- In-hospital and 30-day mortality
- Composite of in-hospital mortality, CVA, AKI, AMI
- Duration of MV, ICU and hospital LOS
- Adverse events directly attributable to IABC
- Six month quality of life
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38474 0
Dr Ed Litton
Address 38474 0
Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000
Country 38474 0
Australia
Phone 38474 0
+61 08 9224 2244
Fax 38474 0
Email 38474 0
ed.litton@health.wa.gov.au
Contact person for public queries
Name 38475 0
Dr Ed Litton
Address 38475 0
Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000
Country 38475 0
Australia
Phone 38475 0
+61 08 9224 2244
Fax 38475 0
Email 38475 0
ed.litton@health.wa.gov.au
Contact person for scientific queries
Name 38476 0
Dr Ed Litton
Address 38476 0
Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000
Country 38476 0
Australia
Phone 38476 0
+61-08-9224 2244
Fax 38476 0
Email 38476 0
ed.litton@health.wa.gov.au

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