Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
19/09/2024

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.
Timepoint [1] 0 0
induction of anaesthesia for cardiac surgery up to 90 days post operatively
Secondary outcome [1] 0 0
Correction of anemia following administration of trial drug to day of surgery measure by hemoglobin
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
Timepoint [2] 0 0
induction of anaesthesia for cardiac surgery to 30 days post operatively
Secondary outcome [3] 0 0
hospital stay
Timepoint [3] 0 0
induction of anaesthesia for cardiac surgery to 30 days post operatively
Secondary outcome [4] 0 0
Disability-free survival
Timepoint [4] 0 0
180 days from induction of anaesthesia for cardiac surgery
Secondary outcome [5] 0 0
90-day survival
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
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
Timepoint [7] 0 0
induction of anaesthesia for cardiac surgery up to 180 days post operatively
Secondary outcome [8] 0 0
Cost-effectiveness
Timepoint [8] 0 0
From trial drug administration to 180 days from induction of anaesthesia for cardiac surgery
Secondary outcome [9] 0 0
Days alive and out of hospital.
Timepoint [9] 0 0
induction of anaesthesia for cardiac surgery up to 30 days post operatively

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2024
Sample size
Target
1000
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
Government body
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/study/NCT02632760
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.
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
[email protected]
Contact person for scientific queries



Summary Results

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