ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609000596202

Ethics application status

Approved

Date submitted

13/07/2009

Date registered

20/07/2009

Date last updated

29/02/2012

Type of registration

Retrospectively registered

Titles & IDs

Public title

A prospective randomised trial to study the effect of intravenous iron infusion versus oral iron therapy in pre-operative anaemia

Scientific title

A prospective randomised trial to study the effect of intravenous iron infusion versus oral iron therapy on pre-operative haemoglobin levels and peri-operative blood transfusion requirement in patients with pre-operative anaemia

Secondary ID [1]

Evaluate patient outcome after treatment of preoperative anaemia.

Secondary ID [2]

Evaluation of quality of life.

Universal Trial Number (UTN)

Trial acronym

Pre-Op Anaemia

Linked study record

Health condition

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

Pre-operative anaemia in elective surgery patients e.g. in orthoplasty (hip- and Knee replacement) and gynaecological elective surgery etc...

Condition category

Condition code

Blood

Haematological diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Randomisation: Intravenous iron polymaltose (Ferrosig,SIGMA,australia), oral iron sulphate 250 mg orally (PO) daily. As following: Arm 1: a single dose of intravenous iron polymaltose (Ferrosig,SIGMA,australia) infused over 120 min 3-4 weeks prior to surgery with a variable dose according patient's body weight (iron dose in mg = body weight (maximum 90 kg) in kg x (target Hb - actual Hb in g/L) x constant factor (0.24) + iron depot (500) 3-4 weeks prior to surgery. Arm 2: Oral iron sulphate 250 mg daily 3-4 weeks prior to surgery until the date of surgery. For the intravenous iron polymaltose it will be given as a single dose according body weight infused over 120 minutes, 3-4 weeks prior to surgery. Oral iron sulphate supplementation will be given as 250 mg daily for 3-4 weeks prior to surgery.

A treatment with the addition of vit B12 100 mcg intramuscular single injection 3-4 weeks prior to surgery. was considered as a pilot study within the original trial arms as patients randomly assigned to the Vit B12 versus no treatment in each active treatment group.

Intervention code [1]

Prevention

Comparator / control treatment

Oral iron Supplementation

Control group

Active

Outcomes

Primary outcome [1]

The primary end points will be Haemoglobin (Hb) level pre-operatively via full blood count.

Timepoint [1]

Hb level immediately pre-operatively and 48 hours post-operatively.

Primary outcome [2]

Amount of blood transfusion required during the peri-operative admission via documenation in the patients files.

Timepoint [2]

immediate peri-operative and 72 hours post-operative time.

Secondary outcome [1]

Assessment of quality of life questionnaires including symptoms/signs related to anaemia (scale) and to iron treatment will be reveiwed as well as presence of complications potentially related to anaemia.

Timepoint [1]

SF-36 Quality of Life Questionnaire completed at 6, 12 and 24 weeks post-operatively

Secondary outcome [2]

The secondary objective to test whether addition of one injection of Vit. B12 1000 mcg will make a difference in the preoperative Hb or outcome in each assigned iron group (intravenous or oral). This showed, however, no difference between both primary treatment groups.

Timepoint [2]

immediate Preopertaive Hb as well as postoperative Hb

Eligibility

Key inclusion criteria

The inclusion criteria is a preoperative Hb above 90 g/L but less than 140 g/L for males and 120 g/L for females as compared to the reference normal range and measured at the Launceston General Hospital (LGH) Laboratory.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients with any specific causes for anaemia apart from haematincs deficiency, or a haemoglobin below 90 g/L will be excluded from the study and will be investigated throughly and offered the appropriate treatment according the cause of anaemia. Any hypersensitivity reactions to any of the drugs involved in this study are considered as exclusion criteria. Exclusion criteria: 1. Presence of a specific cause for anaemia apart from haematinic deficiency 2. Vitamin B12/folate deficiency (Megaloblastic anaemia) 3. Myelodysplasia 4 4. Aplastic Anaemia 5. Haemolysis 6. Bone marrow diseases 7. Malignancy 8. Renal insufficiency 9. Other disorders as documented by clinician. A. Documented iron overload status. B.Patients with polycythaemia (according World Health Organization criteria) will be excluded from the normal control group.

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)

An amendment to the Ethics committee made on 15.2.2008 and this was approved by the Ethics Committee on 14.04.2008 to lower the inclusion Hb level to 90 g/L instead of 100 g/L

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

computer-generated random number schedule issued by pharmacy department.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3 / Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/04/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

120

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Clifford Craig medical Research Trust

Address [1]

PO Box 1963 launceston TAS 7250

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Clifford Craig Medical Research Trust

Address

PO Box 1963 launceston TAS 7250

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Department of Surgery,Launceston General Hospital

Address [1]

Launceston General Hospital Charles ST Launceston TAS 7250

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Tasmania Health and Medical Human Research Ethics Committee EC00337

Ethics committee address [1]

Executive Officer University of Tasmania Research and Development Office GPO Box 252-01 Hobart Tas 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/09/2006

Ethics approval number [1]

H0008960

Summary

Brief summary

Analysis of 175 patients (median age 65 range 53-77 years) who underwent orthopaedic surgery at the Launceston General Hospital (LGH) during the last 4 months revealed that approximately 25-30% of the patients had mild anaemia (Hb>100 g/L and below <140 for males and 120 for females). Unfortunately there is no data regarding haematinics deficiency or amount of blood transfusion in this cohort of patients. Hence the importance of this trial to study all of these factors in Tasmanian patients and provide a solution to this problem. To address this problem and improve health services at LGH, we are aiming to study patients with mild anaemia only (Hb>90 g/L) and have no specific cause for anaemia and randomise them between administration of oral iron therapy or intravenously (i.v.) As common practice we have performed 78 iron infusions at a single centre (Holman Clinic) in 2005 and 48 infusions in the last 6 months without a record of a single case of intolerability. All patients who received i.v. iron infusion preceded by premedications with antihistamine and low dose steroids, did not experience any side effects. In summary, this study is dealing with an important problem which is preoperative mild anaemia in orthopaedic patients which is usually significantly increased in this cohort of patients. Also, we are aiming to overcome exposing this group of patients (with low preoperative Hb) to unnecessary blood transfusion with subsequent hazards/complications of blood transfusion and complications of anaemia. Primary objectives: 1. To study the effect of haematinic replacement on peri-operative mild anaemia (Hb>90 g/L) in order to optimise preoperative haemoglobin level in patients who undergoing elective orthopaedic surgery. 2. To reduce pre, peri and postoperative exposure to allogeneic blood transfusion and hence to avoid its subsequent complications/hazards. Bearing in mind that the current shortage of blood supply might lead to cancellation of this type of elective surgery. Secondary objectives of the study: 1. As a pilot study of the effect of vitamin B12 on erythropoeisis in those patients, who are receiving iron therapy 2. To assess patient outcome, recovery and quality of life 3. To assess the benefits in minimising length of hospital stay 4. To obtain additional information on the transfusion needs of non-anaemic patients, and the relationship to their iron status.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc. Prof. Alhossain Khalafallah

Address

Haematology Department
Launceston General Hospital
Charles St
Launceston, Tasmania, 7250

Country

Australia

Phone

+613 6348 7111

Fax

[email protected]

Contact person for scientific queries

Name

[email protected]

Address

Haematology Department
Launceston General Hospital
Charles St
Launceston, Tasmania, 7250

Country

Australia

Phone

+61 3 6348 7111

Fax

[email protected]

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
Dimensions AI	Three-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy	2012	https://doi.org/10.1136/bmjopen-2012-000998

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

Trial Review

Documents added manually

Documents added automatically