Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000430639
Ethics application status
Approved
Date submitted
13/04/2014
Date registered
28/04/2014
Date last updated
1/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Iron REplacement ADvice Study in female donors aged 18-45 years
Scientific title
The acceptance and feasibility of iron replacement advice for female whole blood donors aged 18-45 years.
Secondary ID [1] 284436 0
Nil
Universal Trial Number (UTN)
Trial acronym
READ Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency 291643 0
Condition category
Condition code
Blood 292026 292026 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consented participants will be provided with a brochure prior to their donation which provides advice on how to replenish iron stores after a whole blood donation. The information is provided at each eligible visit during the study period.
Adherence and acceptability will be monitored using a specifically designed questionnaire at 6 weeks after the recruitment visit and again 6 weeks after the 11-13 month visit if the donor attends at this time.

Donors are provided with a study contact number to assist with any queries that may arise after they leave the donor centre.
Intervention code [1] 289187 0
Other interventions
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291912 0
Donor acceptance and adherence measured by a questionnaire which has been specifically designed for this study.
Timepoint [1] 291912 0
6 weeks after recruitment visit and 6 weeks after the 11-13 month visit
Primary outcome [2] 291913 0
Operational feasiblity measured with time-and-motion studies and staff questionnaire.
The staff questionnaire will address perception regarding impacts on workflow for various areas of the donation process.
Timepoint [2] 291913 0
4-6 months after the study commences
Secondary outcome [1] 307803 0
Efficacy:
Donor - Iron status assessed using serum ferritin
Timepoint [1] 307803 0
Ferritin samples at baseline and 11-13 month visit
Secondary outcome [2] 307872 0
Efficacy
Operational - based on eligilbity to donate on return visits
Timepoint [2] 307872 0
For the duration of the study period (13 months)
Secondary outcome [3] 307873 0
Safety- iron overload based on serum ferritin
Timepoint [3] 307873 0
Clinical ferritin taken at the 3rd visit (or after two whole blood donations)

Eligibility
Key inclusion criteria
-Females aged 18-45 (inclusive) on the day of recruitment
-Eligible and intending to donate whole blood
-Made at least one whole blood donation (>300mL) in the last -12 months
-Able to provide written consent
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Therapeutic donors
Autologous donors
Donors who are ineligible to donate (including Hb-related deferrals)
Donors converted to apheresis on the day of the recruitment visit; and
Donors with any of the following:
-A history of allergy to iron supplements
-A history of hereditary haemochromatosis, iron overload or a known genetic predisposition to these conditions.
-A family history of haemochromatosis (and have not been tested to exclude genetic predisposition to the condition); or
-Red cell disorders (i.e. thalassaemia trait, sickle cell trait, G6PD deficiency, hereditary spherocytosis, hereditary elliptocytosis)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All eligible donors will be invited to participate in the study.
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The samples size was calculated to achieve an appropriate precision (+/-5%) around responses to study questionnaire items, incorporating expected reductions in return rates at subsequent donations and adherence to the study programme.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/04/2014
Actual
14/04/2014
Date of last participant enrolment
Anticipated
Actual
6/09/2014
Date of last data collection
Anticipated
Actual
2/12/2015
Sample size
Target
1500
Accrual to date
Final
1404
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 289087 0
Government body
Name [1] 289087 0
Australian governments fund the Australian Red Cross Blood Service via the National Blood Authority.
Country [1] 289087 0
Australia
Primary sponsor type
Other
Name
Australian Red Cross Blood Service
Address
417 St Kilda Road, Melbourne, Vic
3004
Country
Australia
Secondary sponsor category [1] 287750 0
None
Name [1] 287750 0
Address [1] 287750 0
Country [1] 287750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290875 0
Australian Red Cross Blood Service Human Research Ethics Committee
Ethics committee address [1] 290875 0
17 O'Riordan Street
Alexandria
NSW
2015
Ethics committee country [1] 290875 0
Australia
Date submitted for ethics approval [1] 290875 0
Approval date [1] 290875 0
13/02/2014
Ethics approval number [1] 290875 0
2013#15

Summary
Brief summary
Approximately 220-250 mg of iron is lost with each 470 mL whole blood donation. This may result in progressive iron deficiency, ultimately leading to iron deficiency anaemia and deferral at a subsequent attendance. This study will pilot an education program for high risk donors on how to replenish iron stores after donation. The study will evaluate operational feasibility, donor acceptance and efficacy of this program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47718 0
Dr Anthony Keller
Address 47718 0
Australian Red Cross Blood Service
Level 1, 69 Walters Drive, Osborne Park WA 6017
Country 47718 0
Australia
Phone 47718 0
61 (08) 6213 5914
Fax 47718 0
Email 47718 0
akeller@redcrossblood.org.au
Contact person for public queries
Name 47719 0
Dr Joanna Speedy
Address 47719 0
Australian Red Cross Blood Service
301 Pirie Street, Adelaide SA 5000
Country 47719 0
Australia
Phone 47719 0
61 (08) 8112 1389
Fax 47719 0
Email 47719 0
jspeedy@redcrossblood.org.au
Contact person for scientific queries
Name 47720 0
Dr Joanna Speedy
Address 47720 0
Australian Red Cross Blood Service
301 Pirie Street, Adelaide SA 5000
Country 47720 0
Australia
Phone 47720 0
61 (08) 8112 1389
Fax 47720 0
Email 47720 0
jspeedy@redcrossblood.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePostdonation iron replacement for maintaining iron stores in female whole blood donors in routine donor practice: results of two feasibility studies in Australia.2017https://dx.doi.org/10.1111/trf.14173
N.B. These documents automatically identified may not have been verified by the study sponsor.