ANZCTR - Registration

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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]

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

Ischaemic heart disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Surgery

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]

Not applicable

Comparator / control treatment

N/A

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Mortality at 6 months post surgery

Timepoint [1]

6 months post surgery

Secondary outcome [1]

Quality of life as measured by the EQ5D

Timepoint [1]

6 months post surgery

Secondary outcome [2]

adverse events attributable to intra-aortic balloon counterpulsation including local complications, ischaemia to the limb, bleeding, infection and haemolysis

Timepoint [2]

Monitored in a daily basis during the hospital stay

Secondary outcome [3]

mortality within 30 days of surgery

Timepoint [3]

Within 30 days of surgery

Secondary outcome [4]

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]

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?

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]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

North Shore Private Hospital - St Leonards

Recruitment hospital [3]

Royal Perth Hospital - Perth

Recruitment hospital [4]

The Alfred - Prahran

Recruitment postcode(s) [1]

2065 - Royal North Shore Hospital

Recruitment postcode(s) [2]

2065 - St Leonards

Recruitment postcode(s) [3]

6000 - Perth

Recruitment postcode(s) [4]

3181 - Prahran

Funding & Sponsors

Funding source category [1]

University

Name [1]

Cardiothoracic reseach grant scheme

Address [1]

Sydney Medical School Foundation
Sydney Medical School
Room 201, Edward Ford Building A27
The University of Sydney
NSW, 2006

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North shore private hospital human research ethics committee

Ethics committee address [1]

North Shore Private Hospital
3 Westbourne St
St. Leonards, NSW, 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/02/2013

Ethics approval number [1]

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

Dr Ed Litton

Address

Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000

Country

Australia

Phone

+61 08 9224 2244

Fax

ed.litton@health.wa.gov.au

Contact person for public queries

Name

Ed Litton

Address

Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000

Country

Australia

Phone

+61 08 9224 2244

Fax

ed.litton@health.wa.gov.au

Contact person for scientific queries

Name

Ed Litton

Address

Department of Intensive Care Medicine
Royal Perth Hospital
Wellington St
Perth, WA, 6000

Country

Australia

Phone

+61-08-9224 2244

Fax

ed.litton@health.wa.gov.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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