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Trial registered on ANZCTR


Registration number
ACTRN12611000928910
Ethics application status
Approved
Date submitted
29/08/2011
Date registered
30/08/2011
Date last updated
30/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety of a Rapid Infusion Protocol for Administration of Intravenous Iron Polymaltose
Scientific title
This study will assess the immediate (during infusion) and delayed (up to 5 days) adverse events associated with rapid (over 1 hour) administration of intravenous iron polymaltose compared to standard administration (over 6 hours) in patients receiving iron infusions for iron deficiency in a hospital based outpatient setting.
Secondary ID [1] 262941 0
None
Universal Trial Number (UTN)
Trial acronym
RiFe
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency 270667 0
Condition category
Condition code
Diet and Nutrition 270839 270839 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Iron Polymaltose
Dose of iron polymaltose will be calculated based on the patients weight and haemoglobin level. A dosing table will be used in line with the organisations current intravenous iron policy. For participants who have been randomised to receive the rapid infusion the maximum dose of iron they will receive will be capped at 1500mg.
Rapid intravenous administration over approximately 1 hour.
Dose prescribed (up to a maximum of 1500mg) mixed with 250mls of Normal Saline.
Commencement of a test dose at a rate of 40mls/hr for 15 minutes. If tolerated the infusion will be increased to a rate of 250mls/hr until the end of the infusion.
The rapid infusion differs from the standard in that the volume of normal saline is half and the rate of the infusion will be approximately 1 hour as opposed to the standard rate of approximately 6 hours.
Intervention code [1] 269285 0
Treatment: Drugs
Comparator / control treatment
Intravenous Iron Polymaltose
Standard treatment
Dose prescribed (up to 2500mg) mixed with 500mls of Normal Saline.
Commencement of a test dose at a rate of 20mls/hr for 30 minutes then, 40mls/hr for 30 minutes, then 90mls/hr for 30 minutes and then 120mls/hr for the remainder of the infusion.
Control group
Active

Outcomes
Primary outcome [1] 279521 0
The rate of adverse events experienced by participants during the infusion.

Potential adverse events may include; flushing, welts, rash, urticaria, headache, nausea and vomiting and bronchospasm. Less common adverse events may include; joint and muscle spasm, faintness, tachycardia, sweating, dizziness, syncope, hypotension and circulatory collapse, chest and back pain, arthralgia, chills, fever, angioneurotic oedema and generalised lymphadenopathy.
Adverse events will be graded in terms of severity. Mild - no observable patient discomfort. Moderate - observable patient discomfort. Severe - distress or cardiorespiratory compromise. Mild events will be assessed by the registered Nurses giving the infusion. Moderate or severe events will be assessed by a medical officer.
Timepoint [1] 279521 0
During and on completion of the infusion.
Primary outcome [2] 279522 0
The rate of delayed adverse events experienced by participants.
Adverse events will be graded in terms of severity. Mild - no daily activity limitation. Moderate - some daily activity limitation. Severe - requiring bed rest or medical assistance. The events will be assessed by a study investigator through a follow up phone call at 5 days post infusion. This investigator will be blinded as to whether the participant received the standard or the rapid dose.
Timepoint [2] 279522 0
Up to 5 days following infusion.
Secondary outcome [1] 287812 0
The type and severity of adverse events experienced by participants during and in the 5 days following the infusion.
Events during the infusion will be assessed by the registered nurses giving the infusion in the case of mild events and by a medical officer for moderate to severe events. A study investigator will assess delayed events via a telephone call to the participant 5 days following the infusion.
Timepoint [1] 287812 0
During and in the 5 days following infusion.

Eligibility
Key inclusion criteria
Patients with a confirmed diagnosis of iron deficeincy referred to a hospital based out patients department for intravenous iron infusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Class III or IV heart failure.
Left ventricular ejection fraction of <30%.
Chronic kidney disease with an estimated glomerular filtration rate of <15ml/min.
Otherwise deemed at risk of fluid overload.
All who do not currently meet the criteria for iron infusion according to current WDHB policy.
People who have restricted capability to make independent decisions about their participation in the study i.e. those with known cognitive impairment.

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)
All potential participants information sent to study co-ordinator by the out patient unit when a booking has been made for them to receive their inron infusion.
Study co-ordinator will assess suitability for inclusion into study using initial iron infusion referral criteria and electronic medical records.
If criteria met study co-ordinator will contact patient by telephone, inform them of the study and confirm patient is suitable for inclusion. Study co-ordinator will then send out the participant information sheet and consent form.
On day of infusion a study investigator will assess the patient and gain written consent.
Allocation of treatment (allocation concealment).
Registered nurses within the out patients department will, following consent, take the next sequentially numbered opaque envelope containing either the rapid or standard iron administration protocol. They will then proceed to give the iron infusion as stated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment outside Australia
Country [1] 3819 0
New Zealand
State/province [1] 3819 0
Auckland

Funding & Sponsors
Funding source category [1] 269746 0
Self funded/Unfunded
Name [1] 269746 0
Waitemata District Health Board
Country [1] 269746 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ross Henderson
Address
Clinical Haematology
North Shore Hospital
Shakespeare Road, Takapuna
Auckland 0640
Country
New Zealand
Secondary sponsor category [1] 268786 0
None
Name [1] 268786 0
Address [1] 268786 0
Country [1] 268786 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271709 0
Northern X Regional Ethics Committee
Ethics committee address [1] 271709 0
Ethics committee country [1] 271709 0
New Zealand
Date submitted for ethics approval [1] 271709 0
Approval date [1] 271709 0
08/08/2011
Ethics approval number [1] 271709 0
NTX/11/07/060

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33083 0
Address 33083 0
Country 33083 0
Phone 33083 0
Fax 33083 0
Email 33083 0
Contact person for public queries
Name 16330 0
Louise Bobbitt
Address 16330 0
Clinical Haematology (Gingerbread House)
North Shore Hospital
Shakespeare Road
Takapuna, Auckland. 0640
Country 16330 0
New Zealand
Phone 16330 0
+64 9 4868900 ext 3441
Fax 16330 0
+64 9 4868921
Email 16330 0
louise.bobbitt@waitematadhb.govt.nz
Contact person for scientific queries
Name 7258 0
Dr Ross Henderson
Address 7258 0
Clinical Haematology (Gingerbread House)
North Shore Hospital
Shakespeare Road
Takapuna, Auckland. 0640
Country 7258 0
New Zealand
Phone 7258 0
+64 9 4868900
Fax 7258 0
+64 9 4868921
Email 7258 0
ross.henderson@waitematadhb.govt.nz

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
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Documents added automatically
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