Trial Review

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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 information initially 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] 282201 0
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 288720 0
Condition category
Condition code
Blood 289070 289070 0 0
Anaemia
Blood 289071 289071 0 0
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] 286814 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289179 0
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] 289179 0
First 15 min after induction of anaesthesia compared to 30min period around iron infusion (15min during and 15min after)
Secondary outcome [1] 301969 0
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] 301969 0
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?
No
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)
WA
Recruitment hospital [1] 813 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [2] 814 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 6632 0
6008 - Subiaco
Recruitment postcode(s) [2] 6633 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 286967 0
Self funded/Unfunded
Name [1] 286967 0
Country [1] 286967 0
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] 285758 0
None
Name [1] 285758 0
Address [1] 285758 0
Country [1] 285758 0
Other collaborator category [1] 277339 0
Individual
Name [1] 277339 0
Dr Ed O'Loughlin
Address [1] 277339 0
Department of Anaesthesia and Pain Medicine
Fremantle Hospital
Alma St, Fremantle
Western Australia 6969
Australia
Country [1] 277339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289016 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 289016 0
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] 289016 0
Australia
Date submitted for ethics approval [1] 289016 0
Approval date [1] 289016 0
22/10/2012
Ethics approval number [1] 289016 0
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 38806 0
Dr Roger Browning
Address 38806 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008
Country 38806 0
Australia
Phone 38806 0
+61 (08) 9340 2222
Fax 38806 0
+61 (08) 9340 2227
Email 38806 0
[email protected]
Contact person for public queries
Name 38807 0
Dr Roger Browning
Address 38807 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008
Country 38807 0
Australia
Phone 38807 0
+61 (08) 9340 2222
Fax 38807 0
+61 (08) 9340 2227
Email 38807 0
[email protected]
Contact person for scientific queries
Name 38808 0
Dr Roger Browning
Address 38808 0
Department of Anaesthesia and Pain Medicine
King Edward Memorial Hospital for Women
374 Bagot Road, Subiaco
Western Australia 6008
Country 38808 0
Australia
Phone 38808 0
+61 (08) 9340 2222
Fax 38808 0
+61 (08) 9340 2227
Email 38808 0
[email protected]

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Browning RM, Alakeson N, O'Loughlin EJ. Efficacy a... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy and safety of ultra rapid iron polymaltose infusion during general anaesthesia.2017https://dx.doi.org/10.1177/0310057x1704500307
N.B. These documents automatically identified may not have been verified by the study sponsor.