Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000712606
Ethics application status
Approved
Date submitted
24/06/2014
Date registered
4/07/2014
Date last updated
16/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic INtra-aortic BALLoon Counterpulsation in High-Risk Cardiac Surgery: A Pilot Randomised Controlled Trial
Scientific title
High risk patients undergoing prophylactic intraaortic balloon counterpulsation compared with standard care without intraaortic balloon pump: A feasibility study
Secondary ID [1] 284866 0
Nil
Universal Trial Number (UTN)
Trial acronym
PINBALL Pilot RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
 292388 0
Condition category
Condition code
Cardiovascular 292624 292624 0 0
Coronary heart disease
Surgery 292706 292706 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For those trial participants randomized to prophylactic intraaortic balloon counterpulsation (IABC), an intraaortic balloon pump (IABP) will be inserted prior to the commencement of surgery. The timing of the placement of the IABP will be left to the discretion of the treating surgical team and depending on local facilities, policies and expertise, may be placed in the intensive care unit (ICU), cardiac catheter lab, anaesthetic bay or operating theatre (after induction of anaesthesia, but prior to commencement of the surgery). Details of the location and timing of insertion will be recorded. After confirmation of correct placement, IABC will commence 1:1 throughout the surgery and for the first post-operative night in the ICU. Removal of the IABP after the first night in the ICU will be at the discretion of the treating team. General care of the IABP will be according to local institutional policies and protocols.
Intervention code [1] 289672 0
Treatment: Devices
Intervention code [2] 289739 0
Treatment: Surgery
Intervention code [3] 289740 0
Prevention
Comparator / control treatment
For those trial participants randomized to standard care, all usual treatments, pre-operative, anaesthetic, surgical and post-operative will be as per the treating team. The use of IABC prior to surgery will be specifically discouraged and its use would be recorded as a protocol violation. The use of IABC as an adjunct to weaning from cardiopulmonary bypass, or in the ICU post-operatively will be allowed and the incidence of this will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 292462 0
2 or more participants recruited per site per month
Timepoint [1] 292462 0
6 month follow up from date of index cardiac surgery
Primary outcome [2] 292463 0
Greater than or equal to 90% of participants receiving the assigned intervention preoperatively
Timepoint [2] 292463 0
6 month follow up from date of index cardiac surgery
Primary outcome [3] 292464 0
Greater than or equal to 90% of participants with complete follow up i.e. survival status is known at six months post index cardiac surgery.
Timepoint [3] 292464 0
6 month follow up from date of index cardiac surgery
Secondary outcome [1] 309021 0
IABP timing
Timepoint [1] 309021 0
Duration from insertion to removal
Secondary outcome [2] 309022 0
Quality of life using EQ-5D
Timepoint [2] 309022 0
3 months and 6 months
Secondary outcome [3] 309023 0
Balloon pump safety (limb ischaemia, local infection, device failure, bleeding).
Timepoint [3] 309023 0
In-hospital
Secondary outcome [4] 309024 0
Mortality
Timepoint [4] 309024 0
In-hospital, 30-days, 3 months, 6 months
Secondary outcome [5] 309025 0
Morbidity (postoperative acute kidney injury, peak post operative troponin, postoperative cerebrovascular accident)
Timepoint [5] 309025 0
In-hospital
Secondary outcome [6] 309026 0
Composite safety and efficacy outcome (balloon pump-associated limb ischaemia or bleeding, mortality, acute kidney injury, acute myocardial infarction, cerebrovascular accident, quality of life). Quality of life assessed using E!-5D
Timepoint [6] 309026 0
In hospital, 3-months, 6-months
Secondary outcome [7] 309200 0
Length of ICU stay
Timepoint [7] 309200 0
ICU discharge
Secondary outcome [8] 309201 0
Length of Stay Hospital
Timepoint [8] 309201 0
Hospital discharge following index admission.

Eligibility
Key inclusion criteria
1. The patient is listed for cardiac surgery that includes CABG

2. The treating surgical team considers prophylactic IABC may be of benefit

3. Either:
Severely impaired left ventricular function of any cause
Or:
Recent or ongoing myocardial ischaemia+
Or:
Critical coronary artery stenosis

+myocardial ischaemia defined by pain at rest, requirement for IV GTN or heparin, or elevated troponin.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient age <18 years

2. Patient has an IABC, ventricular assist device or ECMO circuit in situ

3. IABC placement is planned for an immediate therapeutic indication (e.g. cardiogenic shock, severe mitral regurgitation)

4. Absolute contraindication to IABC
a. Severe bilateral lower limb peripheral vascular disease or bilateral femoral arterial grafting
b. Moderate or severe aortic regurgitation
c. Abdominal or thoracic aortic aneurysm, severe calcification or dissection
d. Infection overlying bilateral femoral arteries

5. Treating clinician deems enrollment is not in the best interest of the patient

6. Death is imminent and inevitable

7. Weight <40kg

8. Patient is highly unlikely to be contactable at 6 months for follow up

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be centrally randomized in a 1:1 ratio after signed informed consent has been obtained. Randomisation will be via an interactive voice recognition system and will be stratified by site. Randomisation will be simple randomisation using a computerised sequence generation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be centrally randomized in a 1:1 ratio after signed informed consent has been obtained. Randomisation will be via an interactive voice recognition system and will be stratified by site.Randomisation will be simple randomisation using a computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Assuming 90% of participants receive the intervention to which they are assigned (similar to the proportion in other RCTs of IABC), the lower limit of the 95% confidence interval in a pilot RCT of 40 participants is 80.9%. all estimates, 95% CI will be reported. For normally distributed data, mean and standard deviation will be reported, for non-normally distributed data, median and inter-quartile range and numbers and proportions for dichotomous and ordinal data. Where data are missing, the number of observations will be reported.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2015
Actual
5/10/2015
Date of last participant enrolment
Anticipated
1/02/2017
Actual
1/12/2016
Date of last data collection
Anticipated
Actual
1/07/2017
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 2669 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 4489 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 8341 0
6000 - Perth
Recruitment postcode(s) [2] 8342 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [3] 8343 0
3181 - Prahran
Recruitment outside Australia
Country [1] 6174 0
New Zealand
State/province [1] 6174 0
Auckland

Funding & Sponsors
Funding source category [1] 289481 0
Charities/Societies/Foundations
Name [1] 289481 0
Heart Foundation Australia
Country [1] 289481 0
Australia
Funding source category [2] 289482 0
Charities/Societies/Foundations
Name [2] 289482 0
Intensive Care Foundation
Country [2] 289482 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
1 Wellington St
Perth
WA
6000
Country
Australia
Secondary sponsor category [1] 288166 0
None
Name [1] 288166 0
Address [1] 288166 0
Country [1] 288166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291238 0
Royal Perth Hospital
Ethics committee address [1] 291238 0
1 Wellington St
Perth
WA
6000
Ethics committee country [1] 291238 0
Australia
Date submitted for ethics approval [1] 291238 0
01/07/2014
Approval date [1] 291238 0
15/12/2014
Ethics approval number [1] 291238 0
14-104
Ethics committee name [2] 293718 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [2] 293718 0
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [2] 293718 0
Australia
Date submitted for ethics approval [2] 293718 0
20/04/2015
Approval date [2] 293718 0
20/05/2015
Ethics approval number [2] 293718 0
HREC/14/HAWKE/428
Ethics committee name [3] 293719 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [3] 293719 0
Human Ethics
Office of Research Enterprise
University of Western Australia
M459, 35 Stirling Highway
Crawley
6009 WA
Ethics committee country [3] 293719 0
Australia
Date submitted for ethics approval [3] 293719 0
01/08/2014
Approval date [3] 293719 0
02/09/2014
Ethics approval number [3] 293719 0
RA/4/1/7097

Summary
Brief summary
The purpose of the study is to help determine whether, in high risk patients undergoing cardiac surgery, a device known as an intraaortic balloon pump placed prior to surgery to support the heart, reduces serious postoperative complications. The study will also help determine whether a large study to definitively answer this question is feasible.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 49454 0
Dr Edward Litton
Address 49454 0
Intensive Care Unit (ICU)
Royal Perth Hospital (RPH)
1 Wellington St
Perth
WA
6000
Country 49454 0
Australia
Phone 49454 0
+61892242244
Fax 49454 0
Email 49454 0
[email protected]
Contact person for public queries
Name 49455 0
Dr Edward Litton
Address 49455 0
ICU
RPH
1 Wellington St
Perth
WA
6000
Country 49455 0
Australia
Phone 49455 0
+61892242244
Fax 49455 0
Email 49455 0
[email protected]
Contact person for scientific queries
Name 49456 0
Dr Edward Litton
Address 49456 0
ICU
RPH
1 Wellington St
Perth
WA
6000
Country 49456 0
Australia
Phone 49456 0
+61892242244
Fax 49456 0
Email 49456 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProphylactic Intra-Aortic Balloon Counterpulsation in High Risk Cardiac Surgery: The PINBALL Pilot Multicentre, Registry-Linked, Randomised, Controlled Feasibility Trial.2020https://dx.doi.org/10.1016/j.hlc.2019.04.006
N.B. These documents automatically identified may not have been verified by the study sponsor.