Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting

• Register: EUCTR
• Last refreshed on: 30 April 2018
• Main ID: EUCTR2017-004901-41-FI
• Date of registration: 06/04/2018
• Prospective Registration: Yes
• Primary sponsor: Hospital District of Southwestern Finland
• Public title: Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting
• Scientific title: A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting - PREFER-CABG
• Date of first enrolment: 19/04/2018
• Target sample size: 220
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004901-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Finland

Contacts

• Name: Heart Center
• Affiliation: Turku University Hospital

• Name: Heart Center
• Affiliation: Turku University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Patients undergoing non-urgent and non-emergent coronary artery bypass grafting surgery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion criteria:
Iron transport and iron storage parameters above normal population values and iron or hemoglobin metabolism disorders (e.g. hemochromatosis, thalassemia).
Need for urgent or emergent coronary surgery.
Concomitant surgery other than coronary artery surgery planned.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Patients undergoing elective coronary artery bypass grafting surgery, the study investigates the prevention of postoperative infections and blood transfusions.

Intervention(s)

Trade Name: Ferinject
Product Name: Ferinject
Pharmaceutical Form: Solution for injection/infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: In-hospital stay for coronary surgery

Secondary Objective: Investigate if preoperative ferric carboxymaltose administration is effective in improving survival and cardiac function in patients undergoing coronary artery bypass grafting surgery.

Primary end point(s): Postoperative in-hospital nosocomial infections and/or blood transfusions.

Main Objective: Investigate if preoperative ferric carboxymaltose administration is effective in preventing postoperative infections and blood transfusions in patients undergoing coronary artery bypass grafting surgery.

Secondary Outcome(s)

Secondary end point(s): Survival, cardiac function, quality of life, pharmacoeconomics

Timepoint(s) of evaluation of this end point: 360 days postoperatively

Secondary ID(s)

PREFERCABG01

Source(s) of Monetary Support

Vifor Pharma