ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12621000952842

Ethics application status

Approved

Date submitted

22/06/2021

Date registered

21/07/2021

Date last updated

25/04/2024

Date data sharing statement initially provided

21/07/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Hepcidin and Iron Storage Sub-Study: The relationship of hepcidin to patient outcomes after cardiac surgery

Scientific title

Hepcidin and Iron Storage Sub-Study: The relationship of hepcidin to patient outcomes after cardiac surgery

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

This record is a sub-study of NCT04754022.

Health condition

Health condition(s) or problem(s) studied:

Cardiac Surgery

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Surgery

Other surgery

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Patients will be consented for the collection of additional blood tests at -7 to 0 days to index surgery and blood tests at 30 days after cardiac surgery. All Australian participants enrolled in NCT04754022, a randomised controlled trial comparing two commonly used transfusion strategies in those undergoing cardiac surgery, will be co-recruited to this sub-study. The exposure of interest are those receiving the restrictive transfusion strategy as part of the study registered in NCT04754022.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Active control treatment - standard care (patients undergoing liberal transfusion strategy in study NCT04754022).

Control group

Active

Outcomes

Primary outcome [1]

Days Alive and Out of Hospital. This will be assessed from data linkage with medical records or from direct patient inquiry.

Timepoint [1]

30 days after cardiac surgery.

Secondary outcome [1]

Composite outcomes as for TRICS-IV (all-cause mortality, myocardial infarction, new-onset renal failure requiring dialysis or new focal neurological deficit). All clinical events will be assessed through review of the patient medical records.

Timepoint [1]

Within 6 months after cardiac surgery.

Secondary outcome [2]

Haemoglobin concentration.

Timepoint [2]

30 days after cardiac surgery.

Eligibility

Key inclusion criteria

1. Australian participants of the NCT04754022 study

2. Age 18 to 65 years of age

3. Planned cardiac surgery using cardiopulmonary bypass

4. Informed consent obtained

5. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more

Minimum age

18 Years

Maximum age

65 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Patients who are unable to receive or who refuse blood products

3. Patients who are involved in a preoperative autologous pre-donation program

4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device

5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The Australian contribution is planned with recruitment of 500 patients, recruited over 3 years from up to 12 sites. With 50% of anaemic patients having elevated hepcidin levels, 150 anaemic patients would provide 80% power to detect a mean difference of 3 days alive and out of hospital (DAOH) between patients with functional iron deficiency (assuming an SD of 6.5 DAOH). If 30% of cardiac surgical patients are anaemic, then 500 patients will confirm this finding whilst also substantially supporting recruitment for TRICS IV.
Secondary analysis will involve multivariable linear regression modelling to explore the relationship between hepcidin levels and DAOH. The results of our study may be combined with those from other regions following this identical protocol to enable a pooled analysis to increase power and generalisability.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/02/2022

Actual

5/08/2022

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

20/05/2024

Actual

Sample size

Target

500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

Royal Melbourne Hospital - City campus - Parkville

Recruitment hospital [3]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [4]

The Alfred - Melbourne

Recruitment hospital [5]

Flinders Medical Centre - Bedford Park

Recruitment hospital [6]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [7]

Gold Coast University Hospital - Southport

Recruitment hospital [8]

Westmead Hospital - Westmead

Recruitment hospital [9]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [10]

Victorian Heart Hospital - Clayton

Recruitment hospital [11]

Prince of Wales Hospital - Randwick

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3050 - Parkville

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

3004 - Melbourne

Recruitment postcode(s) [5]

5042 - Bedford Park

Recruitment postcode(s) [6]

5000 - Adelaide

Recruitment postcode(s) [7]

4215 - Southport

Recruitment postcode(s) [8]

2145 - Westmead

Recruitment postcode(s) [9]

2050 - Camperdown

Recruitment postcode(s) [10]

3168 - Clayton

Recruitment postcode(s) [11]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (NHMRC) Medical Research Future Fund International Clinical Trial Collaborations Program

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Not applicable

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital Melbourne - Human Research Ethics Committee

Ethics committee address [1]

41 Victoria Parade
Fitzroy
Victoria 3065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/07/2021

Approval date [1]

16/08/2021

Ethics approval number [1]

Summary

Brief summary

This project will be part of a larger international effort that is examining the best way to transfuse patients who are 65 years old or younger and undergoing cardiac surgery, We will determine if there is an association between baseline hepcidin values and patient outcomes 28 days after cardiac surgery, after taking into account iron storage, haemoglobin values, transfusion strategy and other factors known to influence cardiac surgical outcomes, which has not been examined previously. We will also explore the association between hepcidin and the recovery of haemoglobin levels back to normal 30 days post-surgery after accounting for other factors that may cause haemoglobin to recover slowly.

Trial website

https://medicine.unimelb.edu.au/research-groups/critical-care-research/critcare/appmu/trics-iv-trial

Public notes

A link to the main TRICS IV trial (of which this record is a sub-study) -https://clinicaltrials.gov/ct2/show/NCT04754022

Sponsor website - https://medicine.unimelb.edu.au/research-groups/medicine-and-radiology-research/critcare/about-us/trics-iv-trial

Contacts

Principal investigator

Name

Prof David A Scott

Address

St Vincent's Hospital Melbourne PO Box 2900 Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 9231 4252

Fax

David.SCOTT@svha.org.au

Contact person for public queries

Name

David A Scott

Address

St Vincent's Hospital Melbourne PO Box 2900 Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 9231 4252

Fax

David.SCOTT@svha.org.au

Contact person for scientific queries

Name

David A Scott

Address

St Vincent's Hospital Melbourne PO Box 2900 Fitzroy Victoria 3065

Country

Australia

Phone

+61 3 9231 4252

Fax

David.SCOTT@svha.org.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Qualified statistician/ epidemiologist as part of the research team.

Conditions for requesting access:
• -

What individual participant data might be shared?

• Individual participant data underlying published results (each with a unique participant ID code to keep patient identity's confidential) will be available upon request to the Principal Investigator.

What types of analyses could be done with individual participant data?

• Research/meta-analysis only, upon reasonable request, with data-sharing agreement and a statistical analysis plan.

When can requests for individual participant data be made (start and end dates)?

From:
12-36 months after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Data will be entered by sites in the REDCap™ eCRF system. This is a secure, web-based application hosted at St. Michael’s Hospital (SMH) in Toronto, Canada and is managed by the Applied Health Research Centre in Toronto, Canada. Data will be stored within the SMH data centre on a dedicated hardware platform. Data requests can be emailed to the Principal Investigator at David.SCOTT@svha.org.au.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
14846	Study protocol					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.

Trial Review

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