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Trial registered on ANZCTR


Registration number
ACTRN12611001256965
Ethics application status
Approved
Date submitted
4/12/2011
Date registered
7/12/2011
Date last updated
7/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital
Scientific title
Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital (LGH).
Secondary ID [1] 273531 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The study is to assess the prevalence of preoperative anaemia at the Tasmanian population and to offer the most appropriate treatment preoperatively. 279331 0
Anaemia 279332 0
Condition category
Condition code
Blood 279517 279517 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients with anaemia will be randomised between oral iron sulphate of 325 mg daily until the time of operation and a single iron carboxymaltose infusion 15mg/Kg body weight once only. The control group will receive treatment as per standard care at the LGH.

Outcome measures: by Hb and iron studies.
Intervention code [1] 283844 0
Treatment: Drugs
Comparator / control treatment
Age and sex matched preoperative patients who are not received intervention.
Control group
Active

Outcomes
Primary outcome [1] 286088 0
To assess the efficacy of oral iron versus IV iron in preoperative anaemia setting

Tools: Via Haemoglobin (Hb) and iron studies measurement
Timepoint [1] 286088 0
this timepoint will be measured until the end of the study.
Secondary outcome [1] 295098 0
To assess the prevalence of preoperative anaemia in all elective surgery patients in Tasmanian population. Tools: Via assessment of overall number of patients who will be presented for elective surgery at our institution ( tertiary referral centre for the north of Tasmania, Australia) versus the actual number of anaemic patients according the study criteria during the study period. As screening tool we are using a non-invasive Masimo Pronto-7 device in measuring Hb versus standard laboratory during preoperative screening
Timepoint [1] 295098 0
this timepoint will be measured until the end of the study.
Secondary outcome [2] 295099 0
To assess patient outcome, recovery and quality of life (QoL)Via a dedicated Health related QoL questionnaire.
Timepoint [2] 295099 0
this timepoint will be measured until the end of the study.
Secondary outcome [3] 295100 0
Assess near patient testing with Hb assessment versus standard Hb measurement.
Tools: Correlation between both Hb readings at the same time.
Timepoint [3] 295100 0
this timepoint will be measured until the end of the study.
Secondary outcome [4] 295101 0
Measurements of operative outcome and the complications of the procedure for all groups.
Tools: via a dedicated form recording all characteristics of the operative intervention in correlation with the outcome.
Timepoint [4] 295101 0
this timepoint will be measured until the end of the study.

Eligibility
Key inclusion criteria
The inclusion criteria for anaemic patients in the study will be a haemoglobin level above 85g/L, but < normal level in males and in females as measured by an accredited LGH pathology laboratory in addition to low iron stores.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of a specific cause for anaemia apart from haematinic deficiency
2. Haematological disorders or other malignancies associated with anaemia

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)
These patients will be offered to take part in the study at the Launceston General Hospital (LGH) preadmission clinic over a the trial period. The patients will be randomised after an informed consent form obtained when they are eligible for the study by a dedicated research nurse using a random number schedule. Patients will be randomised to 1) intravenous iron or 2) oral iron therapy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomised block of closed intervention-envelopes prepared by a third party (the Pharmacy Department) will be used by the research coordinator and correlated to a unique patient trial number in order to minimise any possible bias.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study is a prospective, open-label, randomised controlled trial.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
TAS

Funding & Sponsors
Funding source category [1] 284321 0
Hospital
Name [1] 284321 0
Launceston General Hospital
Address [1] 284321 0
Charles street
Launceston, Tasmania 7250
Australia
Country [1] 284321 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Fund
Address
Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Australia
Country
Australia
Secondary sponsor category [1] 283265 0
None
Name [1] 283265 0
Address [1] 283265 0
Country [1] 283265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286284 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 286284 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia
Ethics committee country [1] 286284 0
Date submitted for ethics approval [1] 286284 0
Approval date [1] 286284 0
24/10/2011
Ethics approval number [1] 286284 0
H11973

Summary
Brief summary
The study is a prospective randomised trial screening elective surgical patients from both sexes with full blood count and iron studies during the study period. These patients will be offered to take part in the study at the Launceston General Hospital (LGH). In our interim analysis for a similar orthopaedic trial, approximately 15-20% of patients presented with low haemoglobin in this cohort of patients.

This study is to be conducted by staff working within the Launceston General Hospital, (LGH) recruiting patients from the Northern half of the state of Tasmania and will be a collaborative project involving the Departments of Clinical Haematology, Anaesthesia, Surgery and Pathology as well as University of Tasmania as part of their collaborative work. It has agreement with the Admissions department of the hospital in regards to notification of prospective patients and their hospital booking dates.

All patients who offered to participate in the trial will be counselled on any side effects of the iron therapy. If participants decide to withdraw from the study at any time, it will have no effect on their care or procedure.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33485 0
Prof Professor Alhossain Khalafallah
Address 33485 0
Launceston General Hospital
Charles Street
TAS 7250 Australia
Country 33485 0
Australia
Phone 33485 0
+61367776777
Fax 33485 0
Email 33485 0
khalafallah@dhhs.tas.gov.au
Contact person for public queries
Name 16732 0
Prof Professor Alhossain A. Khalafallah
Address 16732 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Country 16732 0
Australia
Phone 16732 0
+61373487111
Fax 16732 0
+61373487695
Email 16732 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 7660 0
Prof A/Professor Alhossain A. Khalafallah
Address 7660 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Country 7660 0
Australia
Phone 7660 0
+61373487111
Fax 7660 0
+61373487695
Email 7660 0
khalafallah@dhhs.tas.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary