Brief Title
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
Official 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 or Urgent Cardiac Surgery
Brief Summary
This study evaluates the efficacy and safety of single dose preoperative ferric
carboxymaltose in the prevention of postoperative infections and blood transfusions in
patients scheduled for cardiac surgery. Half of the patients will receive ferric
carboxymaltose and half of the patients physiological saline solution as placebo.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Incidence of allogeneic blood transfusion and/or nosocomial infection
Secondary Outcome
Mortality
Condition
Coronary Artery Disease
Intervention
Ferric carboxymaltose
Study Arms / Comparison Groups
Ferric carboxymaltose
Description: Preoperative 1000 mg intravenous single dose as 30 minute infusion
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
210
Start Date
October 2, 2018
Completion Date
December 2021
Primary Completion Date
December 2020
Eligibility Criteria
Inclusion criteria:
1. Patients presenting with cardiac disease requiring surgical operation
2. Open heart surgery is consideredas the best appropriate treatment strategy according
to the current guidelines.
- significant three vessel disease
- left main disease ± single, two or three vessel disease
- two-vessel disease with proximal LAD stenosis
- coronary artery disease requiring revascularization not amenable to percutaneous
coronary intervention
- Aortic valve disease requiring aortic valve surgery
- Mitral valve disease requiring surgical mitral surgery
- Combined surgery for revascularization and valve disease
- surgery of ascending aorta
3. Have provided signed written informed consent
Exclusion Criteria:
1. Age < 35 years
2. Patients requiring , emergency or salvage cardiac surgical operation
3. Participation in another clinical study or treatment with another investigational
product 30 days prior to randomization
4. Moribund patient not expected to survive surgery 12 months after surgery
5. Active malignant disease with a short life expectancy, not eligible for surgery
6. Hemoglobin levels > 155 g/dL for women and >167 g/dl for men (upper reference limits
for TYKSlab)
7. Ferritin levels >150 ug/l for women and >400 ug/l for men.
8. Renal dialysis therapy for chronic renal failure or severe preoperative renal
impairment (eGFR<30ml/min).
9. Study treatment can't be infused during the required time window: minimum 48 hours and
maximum 21 days before the operation.
10. Ongoing oral or parenteral iron medication at the time of randomization
11. Iron or haemoglobin metabolism or synthesis disorders
12. Primary or secondary hemochromatosis (in males and postmenopausal females, a serum
ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum
ferritin value of over 150[17] or 200[18] ng/mL (330 or 440 pmol/L) indicates iron
overload).
13. Porphyria cutanea tarda.
14. Liver failure (Child-Pugh class B or C).
15. Pregnancy.
16. Body weight less than 50kg.
17. Ongoing antibiotic treatment other than prophylactic urine tract infection
antibiotics.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +35823130000, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT03574311
Organization ID
PREFER-CPB01
Responsible Party
Sponsor
Study Sponsor
Turku University Hospital
Collaborators
Vifor Pharma
Study Sponsor
, ,
Verification Date
November 2019