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
ACTRN12614000832673
Ethics application status
Approved
Date submitted
12/06/2014
Date registered
6/08/2014
Date last updated
19/03/2021
Date data sharing statement initially provided
19/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australian and New Zealand Collaborative Perfusion Registry: The establishment and maintenance of a prospective data set on Cardiac Surgical Procedures performed in centres throughout Australia and New Zealand to foster and grow high quality research in the perfusion sciences.
Scientific title
The Australian and New Zealand Collaborative Perfusion Registry: The establishment and maintenance of a prospective data set on Cardiac Surgical Procedures performed in centres throughout Australia and New Zealand to foster and grow high quality research in the perfusion sciences.
Secondary ID [1] 284791 0
ANZCPR
Universal Trial Number (UTN)
U1111-1157-9787
Trial acronym
ANZCPR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Surgery 292165 0
Condition category
Condition code
Cardiovascular 292503 292503 0 0
Other cardiovascular diseases
Surgery 292554 292554 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
30
Target follow-up type
Days
Description of intervention(s) / exposure
Collection of non-identified data from all patients who receive Cardiac Surgery. Data sets include:
1. A demographic data set
2. A preoperative data set to allow appropriate risk stratification of patients
3. A procedural data set to define the surgical procedure(s) for each patient
4. A perfusion data set, designed to encompass as much detail related to the performance of cardiopulmonary bypass as is considered able to be collected in a sustainable and in an ongoing manner continuous variables flow, pressure, temperature);
5. A post-operative data set to allow appropriate outcome measurements to be reported
6. Electronic perfusion data from the heart-lung machine (HLM) data management system.

Duration of Follow-up per patient is 30 days.
Intervention code [1] 289581 0
Not applicable
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292363 0
To collect the following outcome variables for all Cardiac Surgery patients: death in hospital; discharge destination; mortality within 30 days of surgery; mortality date; mortality location; stroke in hospital; encephalopathy in hospital; new continuous coma > 24 hours; new renal failure; intubation duration; ICU stay duration; length of hospital stay; admission date; surgery date; discharge date; length of post-operative stay.
Timepoint [1] 292363 0
30 days post Cardiac Surgery Discharge
Secondary outcome [1] 309785 0
Nil
Timepoint [1] 309785 0
Nil

Eligibility
Key inclusion criteria
All adult patients undergoing cardiac surgical procedures, with or without cardiopulmonary bypass (CPB), will be registered in the database. A full data set will only be collected on patients who undergo surgical procedure with CPB.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
N/A

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Methods of statistical analysis to be used in research activities by groups seeking access to the data stored on ANZCPR will be reviewed by the Steering Committee and the groups local Human Research Ethics Committee. Reports to contributing units can be generated on request.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2007
Actual
1/03/2007
Date of last participant enrolment
Anticipated
31/12/2099
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100000
Accrual to date
38000
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 2616 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 2617 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [3] 2618 0
Ashford Community Hospital - Ashford
Recruitment hospital [4] 2619 0
Royal Hobart Hospital - Hobart
Recruitment hospital [5] 2621 0
Westmead Hospital - Westmead
Recruitment hospital [6] 2622 0
The Alfred - Prahran
Recruitment hospital [7] 2624 0
Cabrini Hospital - Prahran - Prahran East
Recruitment hospital [8] 11710 0
John Hunter Hospital - New Lambton
Recruitment hospital [9] 11711 0
Calvary Health Care Tasmania - Hobart - Lenah Valley
Recruitment outside Australia
Country [1] 6135 0
New Zealand
State/province [1] 6135 0
Auckland

Funding & Sponsors
Funding source category [1] 289405 0
Self funded/Unfunded
Name [1] 289405 0
N/A
Country [1] 289405 0
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Drive, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 288088 0
None
Name [1] 288088 0
Address [1] 288088 0
Country [1] 288088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291164 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 291164 0
Office for Research, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042
Ethics committee country [1] 291164 0
Australia
Date submitted for ethics approval [1] 291164 0
12/05/2009
Approval date [1] 291164 0
17/06/2009
Ethics approval number [1] 291164 0
149/09
Ethics committee name [2] 291165 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [2] 291165 0
Office of Research Services
University of Tasmania
Private Bag 1
Hobart TAS 7001
Ethics committee country [2] 291165 0
Australia
Date submitted for ethics approval [2] 291165 0
02/07/2008
Approval date [2] 291165 0
11/07/2008
Ethics approval number [2] 291165 0
H0010158
Ethics committee name [3] 291166 0
The Alfred Human Research Ethics Committee
Ethics committee address [3] 291166 0
Office of Ethics & Research Governance
Ground Floor, Linay Pavilion,
The Alfred
Commercial Road
Melbourne VIC 3004
Australia
Ethics committee country [3] 291166 0
Australia
Date submitted for ethics approval [3] 291166 0
02/10/2012
Approval date [3] 291166 0
07/05/2013
Ethics approval number [3] 291166 0
454/12
Ethics committee name [4] 291167 0
Cabrini Human Research Ethics Committee
Ethics committee address [4] 291167 0
183 Wattletree Road
Malvern VIC 3144
Australia
Ethics committee country [4] 291167 0
Australia
Date submitted for ethics approval [4] 291167 0
12/01/2011
Approval date [4] 291167 0
24/01/2011
Ethics approval number [4] 291167 0
05-24-01-11
Ethics committee name [5] 291168 0
Sydney West Area Health Service Human Research Ethics Committee
Ethics committee address [5] 291168 0
Research Office
Room 2020 Clinical Sciences
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Ethics committee country [5] 291168 0
Australia
Date submitted for ethics approval [5] 291168 0
09/03/2010
Approval date [5] 291168 0
20/04/2010
Ethics approval number [5] 291168 0
SAC2010/4/5

Summary
Brief summary
The ANZCPR group is a collaborative network of perfusion and interested researchers, who share the commitment to cooperation and collaboration in the pursuit of excellence in perfusion. The ANZCPR group are uniquely positioned to promote the establishment of a unique source of information for the Cardiac Surgical (Perfusion) community, and thus to meet the following vision and mission statements.

Vision: Empower all Cardiac Surgery Team Members to improve the understanding and practice of cardiopulmonary bypass to improve cardiac surgical patient outcomes.

Mission: Maintain and develop the Australian and New Zealand Collaborative Perfusion Registry for cardiac surgical procedures performed throughout Australia and New Zealand.
Promote the reporting and understanding of the effect of cardiopulmonary bypass on patient outcomes through encouraging evidence based practices, quality assurance, quality improvement and research.

The ANZCPR group (formally known as Perfusion Downunder Collaboration (PDUC)) has evolved from the successful Perfusion Downunder (PDU) organisation which was established in 2005. The objectives of PDU were summarised in their mission statement, “to promote original prospective research into the effects of perfusion management on patient outcomes and so validate perfusion practices and interventions throughout Australia and New Zealand". This is being achieved through a meeting of scientific rigour that engages a faculty of excellence with objectives that meet those of the mission statement. The long term objective is to grow perfusionist generated research initiatives, and to seek scientific based consensus on various perfusion strategies. An overriding objective is to foster networking both scientifically and personally within the perfusion profession. The ANZCPR collaboration is an associated entity with the PDU organisation which is sponsored by Cellplex Pty Ltd. The ANZCPR collaboration is governed by a clinical steering committee independent of the sponsor.
Trial website
https://www.anzcpr.org
Trial related presentations / publications
See attachments 1-4 in the 'Attachment" section on the ANZCTR Record
Public notes
PLEASE NOTE: Data is retrospective to Ethics Committee (EC) approval dates as 4 sites started prospectively collecting data from 2007 - EC approval at the institutions involved was not required at the time for the collection of non-identifiable data onto a database, however an EC audit application and approval was required if requesting to audit the data. This changed in 2008/2009 and so EC applications were made at all institutions from that time forward.
Attachments [1] 78 78 0 0
/AnzctrAttachments/366527-18853827_2008, Newland.pdf
Attachments [2] 79 79 0 0
/AnzctrAttachments/366527-21449240 2011, Tuble.pdf
Attachments [3] 80 80 0 0
/AnzctrAttachments/366527-22730861 2012, Baker.pdf

Contacts
Principal investigator
Name 49166 0
Prof Robert A Baker
Address 49166 0
Cardiac Surgery Quality and Outcomes Unit and Perfusion Department, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042 AUSTRALIA
Country 49166 0
Australia
Phone 49166 0
+61 8 8404 2015
Fax 49166 0
+61 8 8404 2019
Email 49166 0
[email protected]
Contact person for public queries
Name 49167 0
Prof Robert A Baker
Address 49167 0
Cardiac Surgery Quality and Outcomes Unit and Perfusion Department, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042 AUSTRALIA
Country 49167 0
Australia
Phone 49167 0
+61 8 8404 2015
Fax 49167 0
+61 8 8404 2019
Email 49167 0
[email protected]
Contact person for scientific queries
Name 49168 0
Prof Robert A Baker
Address 49168 0
Cardiac Surgery Quality and Outcomes Unit and Perfusion Department, Flinders Medical Centre, Flinders Drive, Bedford Park SA 5042 AUSTRALIA
Country 49168 0
Australia
Phone 49168 0
+61 8 8404 2015
Fax 49168 0
+61 8 8404 2019
Email 49168 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD data will not be made available - Non-identifiable data is captured and kept on a central server at Flinders Medical Centre as part of the ANZCPR Registry. Reports to each site and institution are published for quality improvement, quality control and research purposes.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11085Study protocol https://www.anzcpr.org/documents[email protected] 366527-(Uploaded-12-11-2019-16-56-13)-Study-related document.pdf
11086Informed consent form  [email protected] 366527-(Uploaded-12-11-2019-16-59-00)-Study-related document.docx
11087Ethical approval  [email protected] 366527-(Uploaded-12-11-2019-16-59-42)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.