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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] 304551 0
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 321673 0
Condition category
Condition code
Cardiovascular 320280 320280 0 0
Other cardiovascular diseases
Surgery 320480 320480 0 0
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] 320358 0
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] 327359 0
Days Alive and Out of Hospital. This will be assessed from data linkage with medical records or from direct patient inquiry.
Timepoint [1] 327359 0
30 days after cardiac surgery.
Secondary outcome [1] 394736 0
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] 394736 0
Within 6 months after cardiac surgery.
Secondary outcome [2] 394737 0
Haemoglobin concentration.
Timepoint [2] 394737 0
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?
No
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
97
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 19229 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 19230 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 19232 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 19233 0
The Alfred - Melbourne
Recruitment hospital [5] 19235 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [6] 19236 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 19774 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 19907 0
Westmead Hospital - Westmead
Recruitment hospital [9] 26047 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [10] 26482 0
Victorian Heart Hospital - Clayton
Recruitment hospital [11] 26483 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 33803 0
3065 - Fitzroy
Recruitment postcode(s) [2] 33804 0
3050 - Parkville
Recruitment postcode(s) [3] 33806 0
3084 - Heidelberg
Recruitment postcode(s) [4] 33807 0
3004 - Melbourne
Recruitment postcode(s) [5] 33809 0
5042 - Bedford Park
Recruitment postcode(s) [6] 33810 0
5000 - Adelaide
Recruitment postcode(s) [7] 34416 0
4215 - Southport
Recruitment postcode(s) [8] 34607 0
2145 - Westmead
Recruitment postcode(s) [9] 41894 0
2050 - Camperdown
Recruitment postcode(s) [10] 42472 0
3168 - Clayton
Recruitment postcode(s) [11] 42473 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 308423 0
Government body
Name [1] 308423 0
National Health and Medical Research Council (NHMRC) Medical Research Future Fund International Clinical Trial Collaborations Program
Country [1] 308423 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Office of Research, Ethics and Integrity
The University of Melbourne
Victoria, 3010 Australia
Country
Australia
Secondary sponsor category [1] 309257 0
None
Name [1] 309257 0
Not applicable
Address [1] 309257 0
Not applicable
Country [1] 309257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308384 0
St Vincent's Hospital Melbourne - Human Research Ethics Committee
Ethics committee address [1] 308384 0
41 Victoria Parade
Fitzroy
Victoria 3065
Ethics committee country [1] 308384 0
Australia
Date submitted for ethics approval [1] 308384 0
06/07/2021
Approval date [1] 308384 0
16/08/2021
Ethics approval number [1] 308384 0

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
Trial related presentations / publications
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 110526 0
Prof David A Scott
Address 110526 0
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country 110526 0
Australia
Phone 110526 0
+61 3 9231 4252
Fax 110526 0
Email 110526 0
[email protected]
Contact person for public queries
Name 110527 0
David A Scott
Address 110527 0
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country 110527 0
Australia
Phone 110527 0
+61 3 9231 4252
Fax 110527 0
Email 110527 0
[email protected]
Contact person for scientific queries
Name 110528 0
David A Scott
Address 110528 0
St Vincent's Hospital Melbourne
PO Box 2900
Fitzroy
Victoria 3065
Country 110528 0
Australia
Phone 110528 0
+61 3 9231 4252
Fax 110528 0
Email 110528 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will 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.
When will data be available (start and end dates)?
12-36 months after publication
Available to whom?
Qualified statistician/ epidemiologist as part of the research team.
Available for what types of analyses?
Research/meta-analysis only, upon reasonable request, with data-sharing agreement and a statistical analysis plan.
How or where can data be obtained?
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 [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14846Study protocol    381867-(Uploaded-27-01-2022-15-48-36)-Study-related document.pdf



Results publications and other study-related documents

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