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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02632760
Registration number
NCT02632760
Ethics application status
Date submitted
7/12/2015
Date registered
17/12/2015
Titles & IDs
Public title
Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
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Scientific title
Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
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Secondary ID [1]
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605/15
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Universal Trial Number (UTN)
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Trial acronym
ITACS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anaemia
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Condition category
Condition code
Blood
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Anaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ferric carboxymaltose
Treatment: Drugs - Placebo
Active comparator: ferric carboxymaltose - ferric carboxymaltose 1000 mg or Iron isomaltoside 1000 mg given Intravenously
Placebo comparator: Placebo - Placebo intravenous infusion
Treatment: Drugs: Ferric carboxymaltose
treatment for Iron deficient anaemia
Treatment: Drugs: Placebo
placebo - no active drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Days alive and out of hospital.
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Assessment method [1]
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90 days post surgery. the number of days the patient was not in hospital or care facility during the 90 day period from surgery.
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Timepoint [1]
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induction of anaesthesia for cardiac surgery up to 90 days post operatively
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Secondary outcome [1]
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Correction of anemia following administration of trial drug to day of surgery measure by hemoglobin
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Assessment method [1]
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following administration of trial drug to day of surgery. Analysis of the Haemoglobin changes.
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Timepoint [1]
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from administration of trial drug up to induction of anaesthesia for cardiac surgery up to 10 weeks
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Secondary outcome [2]
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Intensive care stay
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Assessment method [2]
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Total days in hospital and Intensive care from induction of anaesthesia for cardiac surgery up until 30 days post operation
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Timepoint [2]
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induction of anaesthesia for cardiac surgery to 30 days post operatively
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Secondary outcome [3]
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hospital stay
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Assessment method [3]
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Total days in hospital from induction of anaesthesia for cardiac surgery up until 30 days post operation
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Timepoint [3]
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induction of anaesthesia for cardiac surgery to 30 days post operatively
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Secondary outcome [4]
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Disability-free survival
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Assessment method [4]
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Using the WHODAS to measure disability post operatively up to180 days from surgery. disability will be measured as an increased score of =4 for a period of = 3months
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Timepoint [4]
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180 days from induction of anaesthesia for cardiac surgery
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Secondary outcome [5]
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90-day survival
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Assessment method [5]
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mortality within 90 days from induction of anaesthesia for cardiac surgery
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Timepoint [5]
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induction of anaesthesia for cardiac surgery up to 90 days post operatively
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Secondary outcome [6]
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units of allogeneic blood transfused
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Assessment method [6]
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number of blood products transfused
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Timepoint [6]
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induction of anaesthesia for cardiac surgery to discharge from hospital up to 30 days
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Secondary outcome [7]
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Quality of life
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Assessment method [7]
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Quality of life after cardiac surgery
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Timepoint [7]
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induction of anaesthesia for cardiac surgery up to 180 days post operatively
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Secondary outcome [8]
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Cost-effectiveness
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Assessment method [8]
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comparative cost analysis for the use of iron v's placebo
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Timepoint [8]
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From trial drug administration to 180 days from induction of anaesthesia for cardiac surgery
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Secondary outcome [9]
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Days alive and out of hospital.
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Assessment method [9]
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30 days post surgery. the number of days the patient was not in hospital or care facility during the 30 day period from surgery.
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Timepoint [9]
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induction of anaesthesia for cardiac surgery up to 30 days post operatively
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Eligibility
Key inclusion criteria
* Patients with anaemia (males Hb <130 g/L, females <120 g/L) undergoing elective cardiac surgery, and available to receive trial drug 1- 10 weeks prior to surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pregnancy
* Known hypersensitivity to study drug (ferric carboxymaltose or equivalent) or its excipients
* Known or suspected haemoglobinopathy/thalassaemia
* Bone marrow disease
* Haemochromatosis
* Renal dialysis
* Erythropoietin or IV iron in the previous 4 weeks
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/07/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3181 - Melbourne
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Funding & Sponsors
Primary sponsor type
Government body
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This randomised double-blind, controlled phase IV trial will compare the efficacy, safety and cost-effectiveness of preoperative IV iron with placebo in patients with anaemia before elective cardiac surgery.
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Trial website
https://clinicaltrials.gov/study/NCT02632760
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Trial related presentations / publications
Cameron MJ, Al Kharusi L, Gosselin A, Baradari PG, Chirico A, Amar-Zifkin A, Yang SS. Iron supplementation for patients undergoing cardiac surgery: a protocol for a systematic review and meta-analysis of randomized controlled trials. CMAJ Open. 2021 Jun 4;9(2):E623-E626. doi: 10.9778/cmajo.20200204. Print 2021 Apr-Jun.
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Public notes
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Contacts
Principal investigator
Name
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Paul S Myles, MD
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Address
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Bayside Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Paul S Myles, MD
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Address
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Country
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Phone
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+61390762000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02632760