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Trial registered on ANZCTR


Registration number
ACTRN12620000314921
Ethics application status
Approved
Date submitted
23/01/2020
Date registered
6/03/2020
Date last updated
10/03/2020
Date data sharing statement initially provided
6/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery
Scientific title
Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery
Secondary ID [1] 300353 0
None
Universal Trial Number (UTN)
Trial acronym
I-SNAPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 315967 0
Condition category
Condition code
Blood 314242 314242 0 0
Anaemia
Surgery 314243 314243 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ferinject ® (Ferric carboxymaltose)
1000mg in 50mL 0.9% sodium chloride
One time intravenous infusion between one and four weeks prior to surgery
Intravenous Infusion
Infusions will be administered at the time of enrolment and attendance at physiological testing. This timing will be dictated by the timing of referral to the Anaesthesia Preoperative Clinic and performance of screening bloods. Treatment will occur as soon as possible after this attendance
Intervention code [1] 316632 0
Treatment: Drugs
Comparator / control treatment
Placebo
1000mg in 50mL 0.9% sodium chloride (the placebo infusion will contain normal saline only and will be administered in opaque syringes and giving sets to mask its contents).
One time intravenous infusion between one and four weeks prior to surgery
Intravenous Infusion
This timing will be dictated by the timing of referral to the Anaesthesia Preoperative Clinic and performance of screening bloods. Treatment will occur as soon as possible after this attendance
Control group
Placebo

Outcomes
Primary outcome [1] 322628 0
Feasibillity of Research Protocol-recruitment rate
Timepoint [1] 322628 0
Six patients per month over a 12 month recruitment period
Primary outcome [2] 322629 0
Feasibility of Research Protocol-patient acceptability. Acceptability will be defined by participation in and completion of the full protocol.
Timepoint [2] 322629 0
Greater than 80% of patients tolerate physiological testing (6 Minute Walk Test (6MWT) and Near Infrared Spectroscopy (NIRS) at the end of 12 month recruitment
Secondary outcome [1] 379097 0
Change in haemogloblin- as part of full blood count; automated analyser or haemoglobinometer. Most methods based on spectrophotometry.
Timepoint [1] 379097 0
At admission and 30 days post-operative
Secondary outcome [2] 379098 0
World Health Organisation Disability Assessment Schedule 2.0 Questionnaire
Timepoint [2] 379098 0
Baseline and 30 days post-operative
Secondary outcome [3] 379099 0
Physical Functioning (6MWT)
Timepoint [3] 379099 0
One week pre-operative and 30 days post operative
Secondary outcome [4] 379100 0
Mitochondrial Function (NIRS)
Timepoint [4] 379100 0
One week pre-operative and 30 days post operative
Secondary outcome [5] 379101 0
Transfusion (number of red cell units transfused during admission) assessed by medical records
Timepoint [5] 379101 0
Admission
Secondary outcome [6] 379102 0
Cost Effectiveness-hospitalisation costs will be calculated using a bottom up approach. These data will be sourced from the health service clinical costing system which captures episode-level costs categorised into relevant cost buckets. These costs will be collected for the relevant admission and any re-admissions within 30 days post discharge.
Timepoint [6] 379102 0
Admission and any re-admissions within 30 days post discharge
Secondary outcome [7] 379677 0
Change in reticulocytes-assessed by fresh blood incubated with:
1. supravital stain for ribosomal RNA and examined by microscopy; or
2. fluorescent dye taken up by RNA and cells counted by flow cytometry.

Most current haematology analysers have reticulocyte modules to perform semi-automated or automated reticulocyte counts. Principle of test depends on the specific instrument.

The absolute reticulocyte count is calculated from the reticulocyte percentage and the red cell count.
Timepoint [7] 379677 0
At admission and 30 days post-operative
Secondary outcome [8] 379678 0
Change in iron stores-assessed by immunoassay
Timepoint [8] 379678 0
At admission and 30 days post-operative

Eligibility
Key inclusion criteria
1. Non-anaemic adults (haemoglobin >130g/L for males and 120g/L for females) 18 years of age or older with ferritin levels < 100 mcg/L
2. Planned elective major surgical procedure with anticipated blood loss greater than 500 ml (as listed in Fiona Stanley Hospital Pre-operative Blood Management algorithm).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Anaemia (defined as per WHO criteria including haemoglobin <130g/L for males and 120g/L for females)
2. Pre-operative evidence of bone marrow insufficiency (i.e. pre-operative haemoglobin <100 g/L, neutrophil count <1.8 x109/L, platelets <100 x109/L) or known haemoglobinopathy
3. Diagnosed iron overload state (e.g. hereditary haemochromatosis)
4. Patients unable/unwilling to receive blood products
5. Pregnancy or lactation
6. Patients administered parenteral iron or erythropoietin within six weeks prior to surgery or with known allergy/hypersensitivity to Ferric carboxymaltose (Ferinject®)
7. Chronic renal disease requiring dialysis
8. Chronic liver disease or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of normal range
9. Patients unable to complete 6MWT
10. Patients unwilling/unable to give consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304776 0
Government body
Name [1] 304776 0
National Blood Authority Australia
Address [1] 304776 0
Level 2, 243 Northbourne Avenue
LYNEHAM ACT 2602
Country [1] 304776 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling Highway
CRAWLEY WA 6009
Country
Australia
Secondary sponsor category [1] 305093 0
None
Name [1] 305093 0
Address [1] 305093 0
Country [1] 305093 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305191 0
South Metropolitan Health Service (Fiona Stanley Hospital)
Ethics committee address [1] 305191 0
11 Robin Warren Drive
MURDOCH WA 6150
Ethics committee country [1] 305191 0
Australia
Date submitted for ethics approval [1] 305191 0
10/12/2019
Approval date [1] 305191 0
26/02/2020
Ethics approval number [1] 305191 0

Summary
Brief summary
Iron infusions are a commonly used therapy to correct iron deficiency anaemia (low blood haemoglobin). They are used with increasing frequency in surgical patients with the aim being to optimise a patient’s own blood stores prior to surgery and improve post-surgical outcomes. International guidelines recommend the pre-operative administration of iron to surgical patients who are not anaemic, but have iron stores considered sub-optimal, when substantial blood loss that would result in depletion postoperatively is anticipated. However, this is based on limited evidence, and with uncertain outcomes.
This pilot study will examine the feasibility and tolerability of a research protocol to compare outcomes (including recovery of iron stores, exposure to blood transfusion and quality of recovery after surgery) in a group of hospital patients having major surgery. Non-anaemic patients with suboptimal iron will either receive an iron infusion pre-operatively or placebo. Patients will be examined by questionnaire, physiological testing and blood tests post-operatively and at one month after their operation to quantify and qualify outcomes for comparison between these groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99554 0
Dr Hamish MACE
Address 99554 0
Department of Anaesthesia, Pain and Perioperative Medicine
South Metropolitan Health Service
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH WA 6150
Country 99554 0
Australia
Phone 99554 0
+61 8 6456 2222
Fax 99554 0
Email 99554 0
Hamish.Mace@health.wa.gov.au
Contact person for public queries
Name 99555 0
Ms Giuliana DAULERIO
Address 99555 0
Faculty of Health and Medical Sciences
Division of Surgery, Medical School
The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009
Country 99555 0
Australia
Phone 99555 0
+61 8 6151 1152
Fax 99555 0
Email 99555 0
giuliana.daulerio@uwa.edu.au
Contact person for scientific queries
Name 99556 0
Dr Hamish MACE
Address 99556 0
Department of Anaesthesia, Pain and Perioperative Medicine
South Metropolitan Health Service
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH WA 6150
Country 99556 0
Australia
Phone 99556 0
+61 8 6456 2222
Fax 99556 0
Email 99556 0
Hamish.Mace@health.wa.gov.au

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 that underlie the results reported in a particular publication(s), after de-identification (text, tables, figures and appendices) will be made available.
When will data be available (start and end dates)?
Immediately following publication, no specified end date.
Available to whom?
Researchers who provide a methodologically sound proposal will be assessed on a case-by-case basis at the discretion of the Chief Principal Investigator, Dr Hamish Mace (E: Hamish.Mace@health.wa.gov.au)
Available for what types of analyses?
Only to achieve the aims in the approved protocol.
How or where can data be obtained?
Access subject to approvals by Chief Principal Investigator, Dr Hamish Mace (E: Hamish.Mace@health.wa.gov.au).
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6582 0
Ethical approval
Citation [1] 6582 0
Link [1] 6582 0
Email [1] 6582 0
giuliana.daulerio@uwa.edu.au
Other [1] 6582 0
Attachment [1] 6582 0
Summary results
No Results