ANZCTR - Registration

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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]

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

Condition category

Condition code

Blood

Anaemia

Blood

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]

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]

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]

Adverse events during the infusion and up to 1 week after.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Frankston Hospital - Frankston

Recruitment postcode(s) [1]

3199 - Frankston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Frankston Hospital

Address [1]

2 Hastings Road, Frankston, Victoria 3199 Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

Office for Research,
Frankston Hospital,
2 Hastings Road,
PO Box 52 
Frankston Vic 3199

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/09/2017

Approval date [1]

03/11/2017

Ethics approval number [1]

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]

/AnzctrAttachments/374041-UltraRIIPHprotocol final HREC approved.docx (Protocol)

Attachments [2]

/AnzctrAttachments/374041-HREC17PH30 Approval Letter 3.11.17.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/374041-PICF Interventional for Self UltraRIIPH 20170818.docx (Participant information/consent)

Contacts

Principal investigator

Name

Mr Iouri Banakh

Address

Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia

Country

Australia

Phone

+61397847602

Fax

+61397842335

ibanakh@phcn.vic.gov.au

Contact person for public queries

Name

Iouri Banakh

Address

Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia

Country

Australia

Phone

+61397847602

Fax

+61397842335

ibanakh@phcn.vic.gov.au

Contact person for scientific queries

Name

Iouri Banakh

Address

Pharmacy Department, Frankston Hospital
2 Hastings Road,
Frankston, Victoria 3199,
Australia

Country

Australia

Phone

+61397847602

Fax

+61397842335

ibanakh@phcn.vic.gov.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

Source	Title	Year of Publication	DOI
Embase	Ultrarapid iron polymaltose infusion for iron deficiency anaemia: a pilot safety study.	2020	https://dx.doi.org/10.1002/jppr.1582

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically