ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001256965

Ethics application status

Approved

Date submitted

4/12/2011

Date registered

7/12/2011

Date last updated

7/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital

Scientific title

Assessment of a single intravenous (IV) iron therapy versus oral iron in the management of preoperative anaemia patients undergoing elective surgery at the Launceston General Hospital (LGH).

Secondary ID [1]

None

Universal Trial Number (UTN)

None

Trial acronym

Linked study record

Health condition

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

The study is to assess the prevalence of preoperative anaemia at the Tasmanian population and to offer the most appropriate treatment preoperatively.

Anaemia

Condition category

Condition code

Blood

Anaemia

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The patients with anaemia will be randomised between oral iron sulphate of 325 mg daily until the time of operation and a single iron carboxymaltose infusion 15mg/Kg body weight once only. The control group will receive treatment as per standard care at the LGH.

Outcome measures: by Hb and iron studies.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Age and sex matched preoperative patients who are not received intervention.

Control group

Active

Outcomes

Primary outcome [1]

To assess the efficacy of oral iron versus IV iron in preoperative anaemia setting

Tools: Via Haemoglobin (Hb) and iron studies measurement

Timepoint [1]

this timepoint will be measured until the end of the study.

Secondary outcome [1]

To assess the prevalence of preoperative anaemia in all elective surgery patients in Tasmanian population. Tools: Via assessment of overall number of patients who will be presented for elective surgery at our institution ( tertiary referral centre for the north of Tasmania, Australia) versus the actual number of anaemic patients according the study criteria during the study period. As screening tool we are using a non-invasive Masimo Pronto-7 device in measuring Hb versus standard laboratory during preoperative screening

Timepoint [1]

this timepoint will be measured until the end of the study.

Secondary outcome [2]

To assess patient outcome, recovery and quality of life (QoL)Via a dedicated Health related QoL questionnaire.

Timepoint [2]

this timepoint will be measured until the end of the study.

Secondary outcome [3]

Assess near patient testing with Hb assessment versus standard Hb measurement.
Tools: Correlation between both Hb readings at the same time.

Timepoint [3]

this timepoint will be measured until the end of the study.

Secondary outcome [4]

Measurements of operative outcome and the complications of the procedure for all groups.
Tools: via a dedicated form recording all characteristics of the operative intervention in correlation with the outcome.

Timepoint [4]

this timepoint will be measured until the end of the study.

Eligibility

Key inclusion criteria

The inclusion criteria for anaemic patients in the study will be a haemoglobin level above 85g/L, but < normal level in males and in females as measured by an accredited LGH pathology laboratory in addition to low iron stores.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

1. Presence of a specific cause for anaemia apart from haematinic deficiency
2. Haematological disorders or other malignancies associated with anaemia

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)

These patients will be offered to take part in the study at the Launceston General Hospital (LGH) preadmission clinic over a the trial period. The patients will be randomised after an informed consent form obtained when they are eligible for the study by a dedicated research nurse using a random number schedule. Patients will be randomised to 1) intravenous iron or 2) oral iron therapy.

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

A randomised block of closed intervention-envelopes prepared by a third party (the Pharmacy Department) will be used by the research coordinator and correlated to a unique patient trial number in order to minimise any possible bias.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

The study is a prospective, open-label, randomised controlled trial.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2012

Actual

31/01/2012

Date of last participant enrolment

Anticipated

Actual

6/11/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

200

Accrual to date

Final

154

Recruitment in Australia

Recruitment state(s)

TAS

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

Charities/Societies/Foundations

Name

Clifford Craig Medical Trust Fund

Address

Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

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]

Date submitted for ethics approval [1]

Approval date [1]

24/10/2011

Ethics approval number [1]

H11973

Summary

Brief summary

The study is a prospective randomised trial screening elective surgical patients from both sexes with full blood count and iron studies during the study period. These patients will be offered to take part in the study at the Launceston General Hospital (LGH). In our interim analysis for a similar orthopaedic trial, approximately 15-20% of patients presented with low haemoglobin in this cohort of patients. 

This study is to be conducted by staff working within the Launceston General Hospital, (LGH) recruiting patients from the Northern half of the state of Tasmania and will be a collaborative project involving the Departments of Clinical Haematology, Anaesthesia, Surgery and Pathology as well as University of Tasmania as part of their collaborative work. It has agreement with the Admissions department of the hospital in regards to notification of prospective patients and their hospital booking dates.  

All patients who offered to participate in the trial will be counselled on any side effects of the iron therapy. If participants decide to withdraw from the study at any time, it will have no effect on their care or procedure.

Trial website

None

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Prof Professor Alhossain Khalafallah

Address

Launceston General Hospital
Charles Street
TAS 7250 Australia

Country

Australia

Phone

+61367776777

Fax

Email

khalafallah@dhhs.tas.gov.au

Contact person for public queries

Name

Professor Alhossain A. Khalafallah

Address

Launceston General Hospital
Charles Street, Launceston, TAS 7250

Country

Australia

Phone

+61373487111

Fax

+61373487695

Email

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

Email

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	Usefulness of non-invasive spectrophotometric haemoglobin estimation for detecting low haemoglobin levels when compared with a standard laboratory assay for preoperative assessment.	2015	https://dx.doi.org/10.1093/bja/aeu403

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