ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12614001261606

Ethics application status

Approved

Date submitted

20/11/2014

Date registered

3/12/2014

Date last updated

21/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessment of a single intravenous iron infusion versus standard care in the management of Post-OPerative Iron (POPi) deficiency anaemia patients undergoing elective surgery at the Launceston General Hospital

Scientific title

Intravenous ferric carboxymaltose versus standard care in the management of postoperative anaemia: A prospective randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Post-OPerative Iron deficiency anaemia trial (POPi)

Linked study record

Health condition

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

post-operative iron deficiency anaemia

Condition category

Condition code

Blood

Anaemia

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients with post-operative anaemia will be randomised between standard care after surgery and a single iron carboxymaltose infusion 15mg/Kg body weight once only infused over 15 minutes within 24-48 hours post-operatively.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

1. Age and sex matched postoperative patients with normal iron stores/Hb postoperatively who receive routine postoperative care after their consent.
2. Patients with post-operative anaemia allocated to the control group receive standard care, which is defined as management of postoperative anaemia with blood transfusion according to hospital guidelines.

Control group

Active

Outcomes

Primary outcome [1]

To assess the efficacy of IV iron in postoperative anaemia setting

Tools: Via full blood count with measurement of Haemoglobin (Hb) and assay of serum iron studies measurement

Timepoint [1]

this timepoint will be measured at discharge, 4 weeks and at the end of the study at 3 months.

Primary outcome [2]

To assess blood transfusion requirement in both groups of patients.

Timepoint [2]

Number of transfused blood units /Amount of blood until discharge

Primary outcome [3]

To assess the prevalence of postoperative iron deficiency anaemia among patients who present to the LGH for elective surgery by recording all anaemic patients versus total number of surgery on the specified trial period.

Timepoint [3]

until the end of study approx 18 months

Secondary outcome [1]

To assess drug safety, and tolerability by a specially designed tolerability assessment form conducted by the treating medical staff during the admission .

Timepoint [1]

until patient discharge

Secondary outcome [2]

patient outcome in termms of recovery postoperatively.

Parameters to be assessed via Postoperative Recovery Profile (PRP), alive status and overall performance at discharge.

Timepoint [2]

by patients discharge.

Secondary outcome [3]

To assess effect on quality of life with SF-36 Quality of Life Questionnaire

Timepoint [3]

By discharge from hospital, 4weeks and 12 weeks postoperatively.

Secondary outcome [4]

To assess post-operative complications in relation to anaemia such as anaemia symptoms requirement for blood transfusion, infection.

This will be done through hospital notes and radiology and laboratory and diagnostics

Timepoint [4]

by discharge until end of study at 3 months.

Secondary outcome [5]

Lenghth of hospital stay (LOS)

Timepoint [5]

Number of days of hospital admission from the operative procedure date till patients discharge date.

Eligibility

Key inclusion criteria

The inclusion criteria for anaemic patients who undergoing elective surgery in the study will be a haemoglobin level equal or above 70 g/L, but < 120 g/L as measured by an accredited LGH pathology laboratory in addition to low iron stores and or low iron saturation equal or <20%.
Patients who undergoing elective surgery with Hb >120 g/L will serve as control group.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Presence of a specific cause for anaemia apart from haematinic deficiency
Patients with active infection and or sepsis

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

This study is to assess the effect of intravenous single iron therapy versus standard care for patients after surgery in the Launceston General Hospital. Patients who receive the standard care and not eligible for the study will be also followed up to assess their outcomes with their consent. The study will be explained in detail to the patients mainly preoperatively, and if necessary postoperatively and a written informed consent will be obtained from all subjects prior to their enrolment.

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

A full patient profile will be obtained including medical and drug history, usual diet and exercise regime. The patient’s demographic and physical detail (weight, height etc) will be measured and recorded.

Eligible patients for the trial will be counselled on any side effects from the iron and ensured that if they decide to withdraw from the study at any time this will in no way affect their care or procedure at the LGH.

The patients will be randomized by an impartial party in the Pharmacy Department to avoid any possible bias using a randomly assigned computed system. The research assistant at enrolment will use the random assigned number schedule issued by the pharmacy. Patients will be randomized initially to 1) intravenous iron or 2) standard care.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary end points will be Hb, iron studies levels at discharge, amount of transfused blood, lenghth of stay at the hospital. The study design is a randomised controlled trial with two-way randomisation. Multivariable analyses will be conducted to compare the outcomes in the two treatment groups, unadjusted and adjusted for actual and potential confounding variables (e.g. age, gender, initial Hb, and operation site, body weight, final post-operative Hb where relevant): post-operative Hb and ferritin levels by repeated measures ANOVA using general linear modelling; peri-operative blood transfusion volumes by Poisson regression.

It is estimated that we would screen about 1000-2000 patients over an 18-24 month period, and that 10% of these would fit the inclusion criteria. Sample size calculations indicate a requirement for 52 completed patients per treatment group for both outcomes based on assumptions: i) a minimum effect size detection of 2g/l increase in postoperative Hb and a 45% reduction in units of blood transfused; ii) an untreated rise in Hb of 0g/l and SD 2.8g/l, and an expected untreated transfusion rate of 2.2 units per patient SD 1.8g/l (data from ‘Iron pre-load for major joint replacement’ Transfusion Medicine 1997; 7: 281-6); iii) alpha value of 0.05 and power of 80% allowing drop-out and missing data. A minimum effect size reduction of 36% in transfusion rate would require 100 patients per group (200 in total).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/12/2014

Actual

15/12/2014

Date of last participant enrolment

Anticipated

31/12/2015

Actual

7/05/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

201

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment postcode(s) [1]

7250 - Launceston

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Launceston General Hospital

Address [1]

Charles street
Launceston, Tasmania 7250
Australia

Country [1]

Australia

Primary sponsor type

University

Name

University of Tasmania

Address

Newnaham Drive
Launceston
Tasmania 7250

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Launceston General hospital

Address [1]

Charles Street
Tasmania
7250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmanian Human Research Ethics Committee

Ethics committee address [1]

University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/11/2014

Ethics approval number [1]

H0014351

Summary

Brief summary

Since 2007, we have conducted several studies assessing preoperative anaemia in different settings including elective surgery. We noted that there was an inherent delay in the management of preoperative anaemia with most of these patients proceeding with the planned surgery without having their iron deficiency anaemia addressed. Despite the improvement in preoperative management, it has been found that there are a significant, although unknown number of patients who have postoperative iron deficiency anaemia. Furthermore, there is lack of data regarding prevalence of postoperative iron deficiency anaemia or amount of blood transfusions in patients who undergo elective surgery. Hence the importance of this trial to study all of these factors in Tasmanian patients attending the Launceston General Hospital in order to provide a pragmatic solution to this problem of postoperative anaemia.

This study is aiming to recruit patients with iron defciency  anaemia and to then randomise them between administration of a single intravenous iron carboxymaltose and standard care.

Participants will be followed up by the research assistant from the time of recruitment/randomisation until 3 months post-operatively. This allows for the completion of a questionnaire regarding their wellbeing at the time, outcome of trial medications, and blood tests as required.

In summary, this study is dealing with an important problem, post-operative anaemia after surgery patients, an issue that to date has not been addressed by our health system, and which is usually significantly increased in this group of patients.

This trial is focusing on treating postoperative anaemia adequately to minimize risk factors of anaemia and to avoid blood transfusion and hence its subsequent complications/hazards. Another possible benefit of this trial is that it will help to relieve the current shortage of blood supply from the Red Cross. We also aim to minimize the patient’s stay in hospital and improve their quality of life.

Iron infusion would be performed in the LGH utilising the currently available facilities. The newly available iron infusion (15 min) is part of standard therapy and is routinely performed in this area without adding extra load to the system.

Trial website

Trial related presentations / publications

Alhossain Khalafallah, Vinod Khelgi, Raghad Al-Badri, Ella Robinson, Carl Yan, Jocelyn Tan, Rizwan Khan, Hung Nguyen and Brian Krikby
INTRAVENOUS IRON CARBOXYMALTOSE VERSUS STANDARD CARE IN THE MANAGEMENT OF POSTOPERATIVE ANAEMIA: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
(Abstract release date: May 21, 2015) EHA Learning Center. Khalafallah A. Jun 12, 2015; 100621 Label: Red blood cells and iron - Clinical 1

http://learningcenter.ehaweb.org/eha/2015/20th/100621/alhossain.khalafallah.intravenous.iron.carboxymaltose.

Public notes

Contacts

Principal investigator

Name

Prof A/Professor Alhossain A. Khalafallah

Address

Launceston General Hospital Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

A/Professor Alhossain A. Khalafallah

Address

Launceston General Hospital Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.gov.au

Contact person for scientific queries

Name

A/Professor Alhossain A. Khalafallah

Address

Launceston General Hospital Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

khalafallah@dhhs.tas.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	Intravenous ferric carboxymaltose versus standard care in the management of postoperative anaemia: a prospective, open-label, randomised controlled trial.	2016	https://dx.doi.org/10.1016/S2352-3026%2816%2930078-3

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically