ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000356763

Ethics application status

Approved

Date submitted

28/03/2013

Date registered

4/04/2013

Date last updated

7/12/2020

Date data sharing statement initially provided

7/12/2020

Date results provided

7/12/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Rapid Administration of iron Polymaltose whilst In the operating Department for patients with iron deficiency

The RAPID Study

Scientific title

A study evaluating the effects of rapid iron polymaltose infusion during general anaesthesia in patients with iron deficiency.

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1141-1370

Trial acronym

The RAPID study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Iron deficiency

Condition category

Condition code

Blood

Anaemia

Blood

Other blood disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intravenous iron polymaltose infusion, dose of 500 - 1000mg (based on body weight and anaemia) over 15 min.
Administration occurs any time after 15min from the start of anaesthesia.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The proportion of patients with systolic BP less than 80mmHg during iron infusion compoared to the proportion of patients with systolic BP less than 80mmHg in the first 15 min after induction of anaesthesia. Statistical comparison using fishers exact test.

Timepoint [1]

First 15 min after induction of anaesthesia compared to 30min period around iron infusion (15min during and 15min after)

Secondary outcome [1]

Absolute difference in systolic blood pressure change during iron infusion compared to after induction of anaesthesia. Statistical analysis using t-test to compare measured difference.

Timepoint [1]

First 15 min after induction of anaesthesia compared to 30min period around iron infusion (15min during and 15min after)

Eligibility

Key inclusion criteria

Female Hb < 120 g/L and ferritin < 100
Male Hb < 130 g/L and ferritin < 100
Iron deficiency alone ferritin < 30
Undergoing general anaesthesia for a procedure

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Pregnancy
- Iron overload (haemochromatosis or haemosiderosis) or ferritin > 100
- Clinically significant renal or liver disease
- Chronic polyarthritis
- Active infection
- Allergy / intolerance to iron polymaltose

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)

Not applicable

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

Phase

Phase 4

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

We are planning a study of independent cases and controls with 1 control(s) per case. Prior data indicate that the failure rate (incidence of hypotension after induction) among controls is 0.2. If the true failure rate ( incidence of hypotension during iron infusion) for experimental subjects is 0.04, we will need to study 85 experimental subjects and 85 control subjects to be able to reject the null hypothesis that the failure rates for experimental and control subjects are equal with probability (power) 0.85. The Type I error probability associated with this test of this null hypothesis is 0.05. We will use a continuity-corrected chi-squared statistic or Fisher’s exact test to evaluate this null hypothesis.

Calculated Sample Size = 85
To adjust for dropouts, failed data collection, or optimistic sample size assumptions we aim to recruit 100 patients.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

28/03/2013

Actual

1/07/2013

Date of last participant enrolment

Anticipated

Actual

1/12/2015

Date of last data collection

Anticipated

Actual

1/04/2016

Sample size

Target

100

Accrual to date

Final

100

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fremantle Hospital and Health Service - Fremantle

Recruitment hospital [2]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Recruitment postcode(s) [2]

6160 - Fremantle

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Dr Roger M Browning

Address

Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Ed O'Loughlin

Address [1]

Department of Anaesthesia and Pain Medicine
Fremantle Hospital
Alma St, Fremantle
Western Australia 6969
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee 
South Metropolitan Area Health Service 
Demountable 3, G Block, Fremantle Hospital

PO Box 480, Fremantle, WA 6959

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

22/10/2012

Ethics approval number [1]

12/201

Summary

Brief summary

The RAPID Study – Lay Description
Rapid Administration of iron Polymaltose whilst In the operating Department

Background, aims & objectives
We aim to show that giving intravenous iron polymaltose over 15 minutes to patients who are under general anaesthesia is safe and not associated with a significant incidence of low blood pressure or other adverse effects. 
Anaemia and iron deficiency are very common in surgical patients, a recent audit at KEMH showed an incidence of around 18%. In patients undergoing surgery it has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patient often suffer from decreased energy,  fatigue and poor ability to concentrate, all of which will affect their quality of life.
Iron polymaltose is an intravenous iron medication commonly used to correct anaemia and iron deficiency. It has been used in Australia for over 40 years, has a very good safety record and about 4-500 women a year receive iron polymaltose at KEMH currently. It is usually administered as a slow infusion over 1.5 – 2.5 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. Low blood pressure can occur less commonly. Serious adverse events such as anaphylaxis are extremely rare and are not related to the speed at which iron polymaltose is given. Oral iron tablets are not effective in many patients for a number of reasons. It would labour intensive, expensive and inconvenient to bring all these patients back to a ward for a 1-2 hour infusion of iron polymaltose after surgery. Many other intravenous iron preparations, with similar pharmacological properties, have been shown to be safe when given over similar short periods of time and we believe this will be the case with iron polymaltose too. Some anaesthetists (in Australia and NZ) have already administered iron polymaltose in this manner with no anecdotal reports of any problems, however we believe it warrants formal evaluation.

Study Population
100 Adult patients with anaemia or iron deficiency, undergoing general anaesthesia.

Study Design and Methods
Prospective, interventional study. Patients will act as their own controls. Temporary low blood pressure is quite common after the initial injection of anaesthetic medications used to start a patients general anaesthetic. We think that the proportion of patients with low blood pressure following iron polymaltose administration will be significantly less than this. We estimate we would need 83 patients, but because we anticipate some dropouts, or incomplete data we aim to recruit 100 (across both sites). Because anaemia is so common we think we should be able to get this many patients in 12 months or less.

Outcomes
Primary outcome will be the incidence of significant low blood pressure following the administration of iron polymaltose (definition = systolic BP less than 80).
Secondary outcomes, will be the incidence of all adverse effects as ascertained by questionnaire 2 hours and 2 days after surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Roger Browning

Address

Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008

Country

Australia

Phone

+61 (08) 9340 2222

Fax

+61 (08) 9340 2227

Roger.Browning@health.wa.gov.au

Contact person for public queries

Name

Roger Browning

Address

Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008

Country

Australia

Phone

+61 (08) 9340 2222

Fax

+61 (08) 9340 2227

Roger.Browning@health.wa.gov.au

Contact person for scientific queries

Name

Roger Browning

Address

Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008

Country

Australia

Phone

+61 (08) 9340 2222

Fax

+61 (08) 9340 2227

Roger.Browning@health.wa.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Efficacy and safety of ultra rapid iron polymaltose infusion during general anaesthesia.	2017	https://dx.doi.org/10.1177/0310057x1704500307

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

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Documents added automatically