Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000448842
Ethics application status
Approved
Date submitted
12/04/2012
Date registered
19/04/2012
Date last updated
30/01/2023
Date data sharing statement initially provided
30/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Intravenous iron therapy reduce the need for blood transfusion and improve post operative blood count following surgery for broken neck of femur.
Scientific title
Intravenous iron infusion to reduce transfusion and post operative haemoglobin in patients with fractured neck of femur
Secondary ID [1] 280316 0
Nil
Universal Trial Number (UTN)
Trial acronym
IronNOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative anaemia 286277 0
Condition category
Condition code
Blood 286505 286505 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Iron Infusion. This will be given as a single 50ml infusion over 15 mins with a dose of up to 1000mg of iron carboxymaltose based on the Ganzoni formula. The infusion will be commenced prior to surgical closure.
Intervention code [1] 284668 0
Treatment: Other
Intervention code [2] 284688 0
Prevention
Comparator / control treatment
Placebo infusion 0.9% saline.
Control group
Placebo

Outcomes
Primary outcome [1] 286936 0
Number of patients in each group receiving blood transfusion during the 30 days post surgery
Timepoint [1] 286936 0
Transfusion history at 30 days
Secondary outcome [1] 297028 0
nadir (lowest perioperative) haemoglobin
Timepoint [1] 297028 0
Electronic patient record interogated at 8 weeks post operatively to determine nadir haemoglobin, 30 day transfusion history and 6 week haemoglobin level.
Secondary outcome [2] 297029 0
Six week haemoglobin
Timepoint [2] 297029 0
Electronic patient record interogated at 8 weeks post operatively to determine six week haemoglobin
Secondary outcome [3] 297030 0
Length of stay
Timepoint [3] 297030 0
Electronic patient record interogated at 8 weeks post operatively to determine length of hospital stay
Secondary outcome [4] 297031 0
Six month mortality
Timepoint [4] 297031 0
Hospital database and WA cemetery board database interogated at 6 months post operatively to establish mortality data.
Secondary outcome [5] 417894 0
Secondary endpoint - transfusion rates excluding major bleeding (>= 4 units)

Electronic assessment of pathology records at 8 weeks post op.

Data collected prospectively (transfusion history to 30 days post op) but post hoc assessment of major bleeding
Timepoint [5] 417894 0
Electronic assessment of pathology records at 8 weeks post op.

Data collected prospectively (transfusion history to 30 days post op) but post hoc assessment of major bleeding
Secondary outcome [6] 417895 0
Secondary outcome - Acute (in hospital) and late infection (until 6 months)
Timepoint [6] 417895 0
Assessed on all patients via electronic medical record assessment and GP contact at 6 months

Eligibility
Key inclusion criteria
Fractured neck of Femur
Surgical fixation planned
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Surgery required in <6 hrs
Haemochromatosis
Previous adverse reaction to Intravenous Iron
Blood transfusion prior to screening

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)
Patients that meet the inclusion criteria will be approached to join the trial and informed consent will be taken. Pateints will then be randomised to either treatment or control groups. This allocation will be kept in hospital pharmacy with access to unblinding information always available via the on-call pharmacist. The patients will be allocated by way of sequentially numbered opaque envelopes with the envelope giving the participant their unique trial number and their group allocation. The patients’ unique medical record number (UMRN) will be linked to their trial number by means of a trial register kept in a locked filing cabinet in each hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 allocation to placebo or treatment groups.
by a computer generated algorithm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Observed reduction in transfusion rates in this patient population (>35% to <20% over the study recruiting period) means the endpoint the study is powered for (reduction in transfusion rates) has occurred independent of the study intervention.
Further, changes to patient consent and recruitment ability in WA for those patients without capacity made the study unachievable.
Date of first participant enrolment
Anticipated
1/07/2012
Actual
18/02/2013
Date of last participant enrolment
Anticipated
Actual
29/05/2017
Date of last data collection
Anticipated
Actual
8/01/2018
Sample size
Target
270
Accrual to date
Final
173
Recruitment in Australia
Recruitment state(s)
QLD,WA,VIC

Funding & Sponsors
Funding source category [1] 285081 0
Hospital
Name [1] 285081 0
Fremantle Hospital
Country [1] 285081 0
Australia
Funding source category [2] 313077 0
Government body
Name [2] 313077 0
Research development unit, Health Department of Western Australia
Country [2] 313077 0
Australia
Funding source category [3] 313078 0
Commercial sector/Industry
Name [3] 313078 0
Vifor Pharma Pty Ltd.
Country [3] 313078 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Fremantle Hospital PO Box 480
Fremantle
WA
6160
Country
Australia
Secondary sponsor category [1] 283947 0
None
Name [1] 283947 0
Address [1] 283947 0
Country [1] 283947 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287096 0
Fremantle Hospital
Ethics committee address [1] 287096 0
Fremantle Hospital
PObox 480
Fremantle
WA 6160
Ethics committee country [1] 287096 0
Australia
Date submitted for ethics approval [1] 287096 0
01/05/2012
Approval date [1] 287096 0
21/09/2012
Ethics approval number [1] 287096 0

Summary
Brief summary
As the population ages there is an increasing number of elderly patients presenting to hospital with fractured hips. A large proportion of these patients receive blood transfusions, a treatment that is associated a significant cost and potential harm. Most of these patients being transfused have an iron deficiency anaemia. We plan to examine the benefit of giving intravenous iron to these patients to see if we can reduce the number needing a blood transfusion and improve nadir haemoglobin and ultimately reduce length of stay and 6 month mortality
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34057 0
Dr Edmond O'Loughlin
Address 34057 0
Department of Anaesthesia and pain medicine
Fiona Stanley Hospital
Murdoch Avenue
Murdoch, Western Australia 6150
Country 34057 0
Australia
Phone 34057 0
+61 408941016
Fax 34057 0
Email 34057 0
edmond.o'[email protected]
Contact person for public queries
Name 17304 0
Edmond O'Loughlin
Address 17304 0
Department of Anaesthesia and pain medicine
Fiona Stanley Hospital
Murdoch Avenue
Murdoch, Western Australia 6150
Country 17304 0
Australia
Phone 17304 0
+61 408941016
Fax 17304 0
Email 17304 0
[email protected]
Contact person for scientific queries
Name 8232 0
Edmond O'Loughlin
Address 8232 0
Department of Anaesthesia
Fiona Stanley Hospital
Murdoch Avenue
Murdoch, Western Australia 6150
Country 8232 0
Australia
Phone 8232 0
+61 408941016
Fax 8232 0
Email 8232 0
edmond.o'[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of study design and ethics approval
Possible on request with additional work and ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18177Study protocol  [email protected]
18178Ethical approval  [email protected]
18179Informed consent form  [email protected]



Results publications and other study-related documents

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