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Trial registered on ANZCTR


Registration number
ACTRN12612000448842
Ethics application status
Not yet submitted
Date submitted
12/04/2012
Date registered
19/04/2012
Date last updated
19/04/2012
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
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 20 mins with a dose of 1000mg of iron polymaltose for patients under 70kg in weight or 1500mg in those over 70kg in weight. The infusion will be commenced following the induction of anaesthesia.
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 paitents in each group receiving blood transfusion during the perioperative period up to 8weeks post operatively
Timepoint [1] 286936 0
Electronic patient record interogated at 8 weeks post operatively to determine transfusion history.
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
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.

Eligibility
Key inclusion criteria
Fractured neck of Femur
Surgical fixation planned
Minimum age
18 Years
Maximum age
No limit
Gender
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?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
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)

Funding & Sponsors
Funding source category [1] 285081 0
Hospital
Name [1] 285081 0
Fremantle Hospital
Address [1] 285081 0
Fremantle Hospital PO Box 480
Fremantle
WA
6160
Country [1] 285081 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
Not yet submitted
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
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
Address 34057 0
Country 34057 0
Phone 34057 0
Fax 34057 0
Email 34057 0
Contact person for public queries
Name 17304 0
Matt Harper
Address 17304 0
Department of Anaesthesia
Fremantle Hospital
PObox 480
WA 4160
Country 17304 0
Australia
Phone 17304 0
+61894313333
Fax 17304 0
Email 17304 0
matthew.harper@health.wa.gov.au
Contact person for scientific queries
Name 8232 0
Matt Harper
Address 8232 0
Department of Anaesthesia
Fremantle Hospital
PObox 480
WA 4160
Country 8232 0
Australia
Phone 8232 0
+61894313333
Fax 8232 0
Email 8232 0
matthew.harper@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results