Trial Review

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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] 280017 0
Evaluate patient outcome after treatment of preoperative anaemia.
Secondary ID [2] 280018 0
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... 236917 0
Condition category
Condition code
Blood 237275 237275 0 0
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] 236706 0
Prevention
Comparator / control treatment
Oral iron Supplementation
Control group
Active

Outcomes
Primary outcome [1] 238086 0
The primary end points will be Haemoglobin (Hb) level pre-operatively via full blood count.
Timepoint [1] 238086 0
Hb level immediately pre-operatively and 48 hours post-operatively.
Primary outcome [2] 238355 0
Amount of blood transfusion required during the peri-operative admission via documenation in the patients files.
Timepoint [2] 238355 0
immediate peri-operative and 72 hours post-operative time.
Secondary outcome [1] 242285 0
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] 242285 0
SF-36 Quality of Life Questionnaire completed at 6, 12 and 24 weeks post-operatively
Secondary outcome [2] 296294 0
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] 296294 0
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?
No
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] 237096 0
Charities/Societies/Foundations
Name [1] 237096 0
Clifford Craig medical Research Trust
Country [1] 237096 0
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] 4600 0
Hospital
Name [1] 4600 0
Department of Surgery,Launceston General Hospital
Address [1] 4600 0
Launceston General Hospital Charles ST Launceston TAS 7250
Country [1] 4600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239195 0
Tasmania Health and Medical Human Research Ethics Committee EC00337
Ethics committee address [1] 239195 0
Executive Officer University of Tasmania Research and Development Office GPO Box 252-01 Hobart Tas 7001
Ethics committee country [1] 239195 0
Australia
Date submitted for ethics approval [1] 239195 0
Approval date [1] 239195 0
20/09/2006
Ethics approval number [1] 239195 0
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 29696 0
Address 29696 0
Country 29696 0
Phone 29696 0
Fax 29696 0
Email 29696 0
Contact person for public queries
Name 12943 0
Assoc. Prof. Alhossain Khalafallah
Address 12943 0
Haematology Department
Launceston General Hospital
Charles St
Launceston, Tasmania, 7250
Country 12943 0
Australia
Phone 12943 0
+613 6348 7111
Fax 12943 0
Email 12943 0
khalafallah@dhhs.tas.gov.au
Contact person for scientific queries
Name 3871 0
khalafallah@dhhs.tas.gov.au
Address 3871 0
Haematology Department
Launceston General Hospital
Charles St
Launceston, Tasmania, 7250
Country 3871 0
Australia
Phone 3871 0
+61 3 6348 7111
Fax 3871 0
Email 3871 0
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
SourceTitleYear of PublicationDOI
Dimensions AIThree-year follow-up of a randomised clinical trial of intravenous versus oral iron for anaemia in pregnancy2012https://doi.org/10.1136/bmjopen-2012-000998
N.B. These documents automatically identified may not have been verified by the study sponsor.