ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000423819

Ethics application status

Not yet submitted

Date submitted

2/04/2012

Date registered

16/04/2012

Date last updated

16/04/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of Rapid Administration of Iron Polymaltose in Patients with Anaemia, Under General Anaesthesia for Routine Surgery. “The RAPID Trial”

Scientific title

An evaluation of adverse events and haemodynamic instability resulting from the rapid administration of iron polymaltose infusion in the operating department, in patients with iron deficiency anaemia under general anaesthesia for elective surgical procedures.

Secondary ID [1]

ANZCA regKey 13/022

Universal Trial Number (UTN)

Trial acronym

RAPID

Linked study record

Health condition

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

Peri-operative Anaemia

Condition category

Condition code

Blood

Anaemia

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

We aim to recruit 100 patients with iron deficiency anaemia or iron deficiency who are scheduled to undergo general anaesthesia for an elective surgical procedure. They will receive an intravenous iron polymaltose infusion over a 10 min period intra operatively, immediately following induction of anaesthesia during a period of haemodynamic stability. The dose given will be determined by the patients body weight and severity of anaemia (as dictated by a previously validated algorithm) up to a maximum dose of 1g. We will collect data on any adverse effects and change in blood pressure over this time and for 15 minutes following the infusion. Changes in blood pressure occuring as a result of the infusion will be compared to the decrease in blood pressure seen at the commencement of the patient's anaesthetic.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

The patients will act as their own control; blood pressure changes secondary to anaesthetic will serve as control measurements against which changes secondary to the intervention are compared.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of significant hypotension (i.e. systolic BP <80mmhg) and tachycardia (heart rate >100).

This will be measured using standard non-invasive blood pressure devices and a 3 lead ECG. All of this equipment is standardised anaesthetic monitoring in place for any general anaesthetic.

Timepoint [1]

Haemodynamic data collection (BP and Heart Rate) at 5 minute intervals commencing before induction of anaesthesia and for 15 minutes following induction of anaesthesia.

Haemodynamic data collection (BP and Heart Rate) at 5 minute intervals commencing before commencement of iron polymaltose during the infusion (10 minutes) and for 15 minutes after completeion of the infusion.

Secondary outcome [1]

Other adverse events.
Headache, nausea, flushing hypotension, muscle cramps.

Timepoint [1]

Questionnaire at 2 hours post operatively. This is a general questionnaire asking about any other symptoms that may or may not be present. It is not intended to use a specific previously validated tool to assess this.

Eligibility

Key inclusion criteria

Iron deficiency anaemia defined as Hb < 120g/L if female or Hb < 130g/L if male with ferritin < 100 or Iron deficiency alone, defined as ferritin < 30

Elective surgery / procedure requiring general anaesthesia

Minimum age

18 Years

Maximum age

100 Years

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)

Patients will be recruited from the routine anaesthetic preassesment clinic which they universlly attend preoperatively. Patients who are found to have iron deficiency anaemia at this preoperative visit will be approached to join the study. All patients wil receive the same treatment.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian and New Zealand College of Anaesthetists

Address [1]

The Chief Executive Officer
Australian and New Zealand College of Anaesthetists
630 St Kilda Road
MELBOURNE VIC 3004

Country [1]

Australia

Primary sponsor type

Hospital

Name

Fremantle Hospital

Address

Alma Street
Fremantle POBOX 480
West Australia
6160

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Fremantle Hospital

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

01/05/2012

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Aim
We aim to show that giving intravenous iron polymaltose over 10 minutes to patients who are under general anaesthesia is convenient, safe and not associated with a significant incidence of low blood pressure or other adverse effects.

 Background
 - Anaemia and iron deficiency are very common in surgical patients.  A recent audit at KEMH, the tertiary womens hospital in WA, showed that 18% of women were anaemic prior to their gynaecological surgery. In patients undergoing surgery anaemia has been linked with an increased risk of needing a blood transfusion, slower recovery from surgery and an increase in postoperative complications. Patients 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 2 - 3 hours in a general ward setting. Common adverse effects can include headache, nausea, flushing, low blood pressure and muscle cramps all of which are not as relevant to patients whilst they are under general anaesthesia. 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. 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 Design and Methods
We aim to recruit 100 patients with iron deficiency anaemia or iron deficiency who are scheduled to undergo general anaesthesia for an elective surgical procedure. Routine care will be unaffected and they will receive general anaesthesia as they would if they were not involved in this trial. Following commencement of surgery and during a period of haemodynamic stability (as assessed by the responsible anaesthetist), they will receive an iron polymaltose infusion over a 10 min period and we will collect data on any adverse effects and change in blood pressure over this time. In order to assess the haemodynamic impact of the infusion, any changes in blood pressure will be compared to the decrease in blood pressure seen at the start of the anaesthetic.

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

Potential Benefits / Ethical Issues
The current drug manufacturers product information sheet, recommends a slow infusion of iron polymaltose over approximately 4.5 hours, however most WA hospitals already administer iron polymaltose over a shorter periods of time, with no serious problems.
We believe that if we demonstrate this technique of administration is safe it may lead to more effective & widespread treatment of iron deficiency and anaemia in surgical patients

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Matthew Harper

Address

Department of Anaesthesia
Fremantle Hospital
Level 5 Block
Alma Street
Fremantle
Western Australia 6160

Country

Australia

Phone

+61 450 832228

Fax

matthew.harper@health.wa.gov.au

Contact person for scientific queries

Name

Dr Matthew Harper

Address

Department of Anaesthesia
Fremantle Hospital
Level 5 Block
Alma Street
Fremantle
Western Australia 6160

Country

Australia

Phone

+61 450 832228

Fax

matthew.harper@health.wa.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

No additional documents have been identified.

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