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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
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