Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001615370
Ethics application status
Approved
Date submitted
23/11/2017
Date registered
11/12/2017
Date last updated
6/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety of iron polymaltose infusion given over 30 and 15 minutes for treatment of iron deficiency.
Scientific title
Ultrarapid iron polymaltose infusion for iron deficiency anaemia: a pilot safety study
Secondary ID [1] 293432 0
Clinical Trial CT-2017-CTN-02874-1 v2
Universal Trial Number (UTN)
Trial acronym
UltraRIIPH pilot study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia 305597 0
Condition category
Condition code
Blood 304820 304820 0 0
Anaemia
Blood 304821 304821 0 0
Normal development and function of platelets and erythrocytes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study interventions include intravenous infusion of iron polymaltose up to 1500 mg in 250 mL sodium chloride 0.9% administered at ultrarapid rates: firstly over 30 minutes and then, should no safety concerns arise, over 15 minutes in a second case series. There will be an interim review of the patients who have received the 30 minute infusions, and if these are found to be safe, then the study will progress to enrol patients into 15 minute infusion series. The doses are adjusted based on level of iron deficiency and comorbidities, as well as patient weight and any blood transfusions as per hospital guidelines.
Intervention code [1] 299674 0
Treatment: Drugs
Comparator / control treatment
The rates and severity of adverse events will be compared to those previously published for iron polymaltose administered over 1 hour and 4 hours, and for ferric carboxymaltose infusions.
Garg M, Morrison G, Friedman A, Lau A. Lau D, Gibson PR. A rapid infusion protocol is safe for total dose iron polymaltose: time for a change. Intern Med J. 2011;41:548-54.
Banakh I, Lam A, Turek M, Htet TD, Vorlander C. et al. Rapid versus standar iron polymaltose infusions: a single centre safety study. J Pharm Pract Res. 2017; 47 (2): 103-109. doi: 10.1002/jppr.1236.
Bregman DB, Goodnough LT. Experience with intravenous ferric carboxymaltose in patients with iron deficiency anemia. Ther Adv Hematol. 2014;5: 48-60.
Browning RM, Alakeson N, O'Loughlin EJ. Efficacy and safety of ultra rapid iron polymaltose infusion during general anaesthesia. Anaesth Intensive Care. 2017; 45 (3): 320-325.
Control group
Historical

Outcomes
Primary outcome [1] 304032 0
The primary outcome is the overall adverse event rate in each group.
Possible side effect: Fever, Headache, Visual changes, Dizziness/hypotension/paleness, Palpitations/arrhythmia, Chest tightness/pain, Mouth numbness and tingling, Peripheral tingling sensation, Flushing/sweaty, Chills/flu-like symptoms, Sensation of throat swelling, Bronchospasm/dysphonia/dry, cough,Shortness of breath, Nausea/vomiting, Back pain/abdominal pain, Rash/itchiness, Welts/swelling at cannula site.
These side effects will be monitored for by medical staff during the infusion and by nursing staff afterwards for 1 hour, and by patients themselves for up to a week post infusion.
Timepoint [1] 304032 0
Adverse events during the infusion and up to 1 week after.
Secondary outcome [1] 340762 0
Secondary outcomes included the severity of adverse events, which will be graded as mild, moderate or severe. Mild reactions will be defined as those that do not require a change in the infusion rate, a change in treatment or prolongation of hospital stay. Moderate reactions will be defined as those that required a change in infusion rate or interruption to the infusion, or required minor treatment such as analgesia or requiring additional monitoring. Severe reactions will be defined as those that required the iron infusion to be stopped without an intention to restart and where patients require urgent medical attention with administration of resuscitation or severe allergic reaction medications such as adrenaline,
hydrocortisone or parenteral antihistamine, or prolongation of hospitalisation (more than 1 day).
These side effects will be monitored for by medical staff during the infusion and by nursing staff afterwards for 1 hour, and by patients themselves for up to a week post infusion. Patients will be contacted 1 week after the infusions by the one of the investigators and medical records will also be reviewed for documentation by medical and nursing staff.
Timepoint [1] 340762 0
Adverse events during the week after infusion administration, and their severity.

Eligibility
Key inclusion criteria
• Frankston Hospital patients diagnosed with iron deficiency anaemia of any cause requiring iron replacement doses of up to 1500 mg.
• Treating team provided consent for their patient to be approached to participate.
• Patients able to provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients requiring doses greater than 1500 mg of iron polymaltose.
• Patients unable to give informed consent.
• Patients unable to read English.
• Treating team declining for their patient to be approached to participate in the study.

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



Intervention assignment
Single group
Other design features
open label phase 4 study
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis
Adverse event rates will be compared using Fisher's exact test, and baseline parameters using Fisher's exact and student-t test or Kruskal Wallis if non-normally distributed data is identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/11/2017
Date of last participant enrolment
Anticipated
31/01/2018
Actual
10/01/2018
Date of last data collection
Anticipated
7/02/2018
Actual
17/01/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9428 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 18138 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 298060 0
Hospital
Name [1] 298060 0
Frankston Hospital
Country [1] 298060 0
Australia
Primary sponsor type
Individual
Name
Iouri Banakh
Address
Pharmacy Department, Frankston Hospital, 2 Hastings Road, Frankston 3199, Victoria, Australia.
Country
Australia
Secondary sponsor category [1] 297135 0
None
Name [1] 297135 0
Address [1] 297135 0
Country [1] 297135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299078 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 299078 0
Office for Research,
Frankston Hospital,
2 Hastings Road,
PO Box 52
Frankston Vic 3199
Ethics committee country [1] 299078 0
Australia
Date submitted for ethics approval [1] 299078 0
20/09/2017
Approval date [1] 299078 0
03/11/2017
Ethics approval number [1] 299078 0
HREC/17/PH/30

Summary
Brief summary
Iron deficiency and anaemia are common conditions. They are treated by increasing your body’s iron levels . The most common way is by mouth as an iron tablet or liquid. Some people may need iron to be given directly into the blood through a vein, and this is called an intravenous (IV) iron infusion. An IV iron infusion is used when tablets or liquids do not work for a person or when they cause side effects such as stomach upset.

In the past, iron polymaltose (a type of IV iron) was only given as an IV infusion over 4 hours. These days, it can be given faster and safely over 1 hour (for doses up to 1500 mg) thanks to the results of recent studies. Another type of IV iron, ferric carboxymaltose, is frequently used and can be given over just 15 minutes. However, it is more expensive and can only deliver a maximum dose of 1000 mg per week. Most people need around 1500 mg to completely top-up their iron and to last them for months or even up to a year. Previous studies suggest that how quickly IV iron is given has no effect on how well this treatment is tolerated. For this reason, the goal of this study is to test the safety of iron polymaltose given over 30, and then potentially over 15 minutes. Safety results will be compared to the slower infusions and to the other type of IV iron, ferric carboxymaltose. If no difference in safety is found, then this could be a better option because patients can be treated with a complete iron top-up and have it done over a shorter period of time. Infusion centres and hospitals would also benefit with reduced nursing time, larger number of patients treated and reduced direct medication costs.

Iron polymaltose has been approved in Australia to treat iron deficiency anaemia since 27 May 1999. However, it is not approved for infusion rates over 15 or 30 minutes. Therefore, it is an experimental method of giving this treatment for iron deficiency anaemia. This means that it must be tested to see if it is as safe as the usual way of giving it over 1 or 4 hours.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2207 2207 0 0
/AnzctrAttachments/374041-UltraRIIPHprotocol final HREC approved.docx (Protocol)
Attachments [2] 2208 2208 0 0
/AnzctrAttachments/374041-HREC17PH30 Approval Letter 3.11.17.pdf (Ethics approval)
Attachments [3] 2209 2209 0 0
/AnzctrAttachments/374041-PICF Interventional for Self UltraRIIPH 20170818.docx (Participant information/consent)

Contacts
Principal investigator
Name 79222 0
Mr Iouri Banakh
Address 79222 0
Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia
Country 79222 0
Australia
Phone 79222 0
+61397847602
Fax 79222 0
+61397842335
Email 79222 0
[email protected]
Contact person for public queries
Name 79223 0
Mr Iouri Banakh
Address 79223 0
Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia
Country 79223 0
Australia
Phone 79223 0
+61397847602
Fax 79223 0
+61397842335
Email 79223 0
[email protected]
Contact person for scientific queries
Name 79224 0
Mr Iouri Banakh
Address 79224 0
Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia
Country 79224 0
Australia
Phone 79224 0
+61397847602
Fax 79224 0
+61397842335
Email 79224 0
[email protected]

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
EmbaseUltrarapid iron polymaltose infusion for iron deficiency anaemia: a pilot safety study.2020https://dx.doi.org/10.1002/jppr.1582
N.B. These documents automatically identified may not have been verified by the study sponsor.