Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001060639
Ethics application status
Approved
Date submitted
1/09/2023
Date registered
4/10/2023
Date last updated
4/10/2023
Date data sharing statement initially provided
4/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mechanistic Observational Study of Anaemia and Inflammation in patients undergoing Cardiac Surgery
Scientific title
A mechanistic, prospective, longitudinal, observational, biobank study of postoperative anaemia and inflammation in patients having cardiac surgery
Secondary ID [1] 310525 0
None
Universal Trial Number (UTN)
Trial acronym
MOSAICS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 331342 0
Cardiovascular disease 331343 0
Recovery from surgery 331344 0
Condition category
Condition code
Cardiovascular 328092 328092 0 0
Other cardiovascular diseases
Surgery 328093 328093 0 0
Other surgery
Blood 328094 328094 0 0
Anaemia
Anaesthesiology 328259 328259 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The majority of data will be collected from the medical record without the need for patient involvement. Patients will be required to undergo a blood test prior to commencement of surgery, and on postoperative days 1, 2, 4, 8, 16, 32 and 64. The first three of these will be performed as an inpatient. The last three will require the patient to return to hospital to have them performed. This will be timed with routine cardiac rehabilitation after surgery. The patient will also undergo a 6 minute walk test on or about days 32 and 64. This again will be incorporated into rehabilitation.
Intervention code [1] 326920 0
Diagnosis / Prognosis
Comparator / control treatment
There will be no comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335961 0
The primary outcome will be the rate of change in haemoglobin concentration in g/L. This will be assessed using a blood test.
Timepoint [1] 335961 0
Measured at multiple timepoints: postoperative day (POD) 1, POD 2, POD 4, POD 8, POD 14, POD 30 and POD 64
Secondary outcome [1] 426257 0
The secondary outcome will be the rate of change in serum hepcidin (ng/L). This will be assessed using a blood test.
Timepoint [1] 426257 0
Measured at multiple timepoints: postoperative day (POD) 1, POD 2, POD 4, POD 8, POD 14, POD 30 and POD 64

Eligibility
Key inclusion criteria
All patients undergoing coronary artery bypass or cardiac valve surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Undergoing cardiac surgery that is not CABG and/or cardiac valve procedures (i.e., ascending aorta or root replacement, solid organ transplantation, etc.)
End-stage renal failure requiring dialysis
Active solid organ malignancy
Taking antibiotic therapy for active infection at time of operation
Acquired/clonal haematological malignancies (including leukaemia, lymphoma, myeloma, myelodysplasia, or aplastic anaemia)
Haemoglobinopathy (including a-globin and/or ß-globin gene mutations [thalassaemia] and sickle cell trait)
Inherited red cell membrane disorders (including glucose-6-phosphate-dehydrogenase and pyruvate kinase deficiency)
Active haemolytic processes (mechanical or autoimmune)
Preoperative requirement for erythropoiesis stimulating agents
Age < 18 years
Pregnancy or breastfeeding
Surgical plan requiring off-pump technique
Preoperative Hb < 130 g/L if male and < 120 g/L if female
Preoperative C-reactive protein (CRP) concentration > 5 mg/L
Emergency surgery (i.e., following decision to operate, the patient proceeds to surgery before the next business day)
Not willing to attend for blood tests following discharge.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The analysis will include all recruitment participants. Participant characteristics at time of enrolment, intra-operative data, hospital discharge data, and interview data at POD 32 and 64 will be summarised descriptively.
Laboratory outcomes (including haemoglobin concentration, reticulocyte count, reticulocyte Hb content, and hepcidin) will be summarised descriptively at each timepoint. As the primary purpose of this study is to describe postoperative changes in Hb and hepcidin (and eventually, other biomarkers listed above) between POD 1 and POD 64, a mixed effects model for repeated measures will be used by outcome. In addition, we will describe the relationship between Hb and hepcidin between POD 1 and POD 64 using a joint model for longitudinal continuous outcomes.
Additional exploratory analyses may be contemplated depending on the collected patient characteristics. These will be detailed in a statistical analysis plan prior to commencing the analysis, and might include:
• Pre-operative inflammatory status (as determined by CRP, albumin and hepcidin)
• Pre-operative iron status (as determined by ferritin or transferrin saturation)
• Duration of cardiopulmonary bypass
• Occurrence of postoperative complication (especially postoperative infection)
• Postoperative iron therapy
• Participant sex (male vs. female)
No multiplicity adjustment will be adopted to let readers use their own judgement about the relative weight of the conclusions given the descriptive nature of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2023
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
3/02/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25480 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 25481 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41292 0
3084 - Heidelberg
Recruitment postcode(s) [2] 41293 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 314728 0
Charities/Societies/Foundations
Name [1] 314728 0
Australian and New Zealand College of Anaesthetists (ANZCA) Foundation
Country [1] 314728 0
Australia
Primary sponsor type
University
Name
Department of Critical Care, The University of Melbourne
Address
159 Barry StreetParkville VIC 3052
Country
Australia
Secondary sponsor category [1] 316703 0
None
Name [1] 316703 0
Address [1] 316703 0
Country [1] 316703 0
Other collaborator category [1] 282807 0
Other
Name [1] 282807 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 282807 0
30 R0yal Parade, Parkvile VIC 3052
Country [1] 282807 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313738 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313738 0
Ethics committee country [1] 313738 0
Australia
Date submitted for ethics approval [1] 313738 0
11/05/2023
Approval date [1] 313738 0
29/08/2023
Ethics approval number [1] 313738 0
HREC/97555/Austin-2023

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129194 0
A/Prof Lachlan Miles
Address 129194 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 129194 0
Australia
Phone 129194 0
+61457891234
Fax 129194 0
Email 129194 0
[email protected]
Contact person for public queries
Name 129195 0
Lachlan Miles
Address 129195 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 129195 0
Australia
Phone 129195 0
+61457891234
Fax 129195 0
Email 129195 0
[email protected]
Contact person for scientific queries
Name 129196 0
Lachlan Miles
Address 129196 0
Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 129196 0
Australia
Phone 129196 0
+61457891234
Fax 129196 0
Email 129196 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?
De-identified IPD for all patient characteristics
When will data be available (start and end dates)?
From publication of primary manuscript until mandated secure document destruction 7 years after the end of the study
Available to whom?
Academic groups not affiliated with industry
Available for what types of analyses?
Systematic review, meta-analysis, individual patient data meta-analysis
How or where can data be obtained?
Direct request from the investigators via email at [email protected].


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
No additional documents have been identified.