ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

I-SNAPS

Linked study record

Health condition

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

Iron deficiency

Condition category

Condition code

Blood

Anaemia

Surgery

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]

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]

Feasibillity of Research Protocol-recruitment rate

Timepoint [1]

Six patients per month over a 12 month recruitment period

Primary outcome [2]

Feasibility of Research Protocol-patient acceptability. Acceptability will be defined by participation in and completion of the full protocol.

Timepoint [2]

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]

Change in haemogloblin- as part of full blood count; automated analyser or haemoglobinometer. Most methods based on spectrophotometry.

Timepoint [1]

At admission and 30 days post-operative

Secondary outcome [2]

World Health Organisation Disability Assessment Schedule 2.0 Questionnaire

Timepoint [2]

Baseline and 30 days post-operative

Secondary outcome [3]

Physical Functioning (6MWT)

Timepoint [3]

One week pre-operative and 30 days post operative

Secondary outcome [4]

Mitochondrial Function (NIRS)

Timepoint [4]

One week pre-operative and 30 days post operative

Secondary outcome [5]

Transfusion (number of red cell units transfused during admission) assessed by medical records

Timepoint [5]

Admission

Secondary outcome [6]

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]

Admission and any re-admissions within 30 days post discharge

Secondary outcome [7]

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]

At admission and 30 days post-operative

Secondary outcome [8]

Change in iron stores-assessed by immunoassay

Timepoint [8]

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

Sex

Both males and females

Can healthy volunteers participate?

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

31/03/2020

Actual

Date of last participant enrolment

Anticipated

26/02/2021

Actual

Date of last data collection

Anticipated

30/04/2021

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Blood Authority Australia

Address [1]

Level 2, 243 Northbourne Avenue
LYNEHAM ACT 2602

Country [1]

Australia

Primary sponsor type

University

Name

The University of Western Australia

Address

35 Stirling Highway
CRAWLEY WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service (Fiona Stanley Hospital)

Ethics committee address [1]

11 Robin Warren Drive
MURDOCH WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/12/2019

Approval date [1]

26/02/2020

Ethics approval number [1]

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

Dr Hamish MACE

Address

Department of Anaesthesia, Pain and Perioperative Medicine
South Metropolitan Health Service
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH WA 6150

Country

Australia

Phone

+61 8 6456 2222

Fax

Hamish.Mace@health.wa.gov.au

Contact person for public queries

Name

Giuliana DAULERIO

Address

Faculty of Health and Medical Sciences
Division of Surgery, Medical School
The University of Western Australia
35 Stirling Highway
CRAWLEY WA 6009

Country

Australia

Phone

+61 8 6151 1152

Fax

giuliana.daulerio@uwa.edu.au

Contact person for scientific queries

Name

Hamish MACE

Address

Department of Anaesthesia, Pain and Perioperative Medicine
South Metropolitan Health Service
Fiona Stanley Hospital
11 Robin Warren Drive
MURDOCH WA 6150

Country

Australia

Phone

+61 8 6456 2222

Fax

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
6582	Ethical approval			giuliana.daulerio@uwa.edu.au

Results publications and other study-related documents

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