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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02632760




Registration number
NCT02632760
Ethics application status
Date submitted
7/12/2015
Date registered
17/12/2015
Date last updated
22/04/2020

Titles & IDs
Public title
Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
Scientific title
Intravenous Iron for Treatment of Anaemia Before Cardiac Surgery
Secondary ID [1] 0 0
605/15
Universal Trial Number (UTN)
Trial acronym
ITACS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days alive and out of hospital. - 30 days post surgery. the number of days the patient was not in hospital or care facility during the 30 day period from surgery.
Timepoint [1] 0 0
induction of anaesthesia for cardiac surgery up to 30 days post operatively
Secondary outcome [1] 0 0
Correction of anemia following administration of trial drug to day of surgery measure by hemoglobin - following administration of trial drug to day of surgery. Analysis of the Haemoglobin changes.
Timepoint [1] 0 0
from administration of trial drug up to induction of anaesthesia for cardiac surgery up to 10 weeks
Secondary outcome [2] 0 0
Intensive care stay - Total days in hospital and Intensive care from induction of anaesthesia for cardiac surgery up until 30 days post operation
Timepoint [2] 0 0
induction of anaesthesia for cardiac surgery to 30 days post operatively
Secondary outcome [3] 0 0
hospital stay - Total days in hospital from induction of anaesthesia for cardiac surgery up until 30 days post operation
Timepoint [3] 0 0
induction of anaesthesia for cardiac surgery to 30 days post operatively
Secondary outcome [4] 0 0
Disability-free survival - 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
Timepoint [4] 0 0
180 days from induction of anaesthesia for cardiac surgery
Secondary outcome [5] 0 0
90-day survival - mortality within 90 days from induction of anaesthesia for cardiac surgery
Timepoint [5] 0 0
induction of anaesthesia for cardiac surgery up to 90 days post operatively
Secondary outcome [6] 0 0
units of allogeneic blood transfused - number of blood products transfused
Timepoint [6] 0 0
induction of anaesthesia for cardiac surgery to discharge from hospital up to 30 days
Secondary outcome [7] 0 0
Quality of life - 180 days from induction of anaesthesia for cardiac surgery
Timepoint [7] 0 0
induction of anaesthesia for cardiac surgery up to 180 days post operatively
Secondary outcome [8] 0 0
Cost-effectiveness - comparative cost analysis for the use of iron v's placebo
Timepoint [8] 0 0
From trial drug administration to 180 days from induction of anaesthesia for cardiac surgery

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02632760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Myles, MD
Address 0 0
Bayside Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul S Myles, MD
Address 0 0
Country 0 0
Phone 0 0
+61390762000
Fax 0 0
Email 0 0
p.myles@alfred.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02632760