Aortic Aneurysm, Thoracic, Aortic Valve Stenosis, Coronary Artery Disease, Mitral Valve Disease, Postoperative Complications
Conditions
Keywords
CABG, cardiac surgery, blood transfusion, intravenous iron, postoperative infection
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.
Interventions
DRUGFerric carboxymaltose
A single dose of drug or placebo is administered preoperatively to participants
OTHERPhysiological saline
Single infusion 100 ml physiological saline infusion preoperatively
Sponsors
Vifor Pharma
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blinding, study drug administration by separate staff blinded from participant and investigators
Intervention model description
Randomized controlled 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients presenting with cardiac disease requiring surgical operation 2. Open heart surgery is considered 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of allogeneic blood transfusion and/or nosocomial infection | 0-90 days | Composite of transfused red blood cell units and/or nosocomial infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU/CCU days | 0-90 days | Days in the ICU (intensive care unit) and/or CCU (cardiac care unit) |
| Perioperative myocardial infarction | 3 days | MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels |
| Length of stay | 0-90 days | Days in hospital |
| Days on vasoactive drugs | 0-90 days | Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.) |
| Ventilator free days | 0-90 days | Days not on ventilator (intubated or non-invasive ventilation) |
| Mortality | 0-90 days | All-cause mortality |
| New onset atrial fibrillation (AF) or flutter | 0-90 days | New AF or flutter (i.e. patient without previous history of AF/flutter) assessed from ECG-telemetry during index hospitalization or ECG-verified AF/flutter after discharge |
| Acute heart failure | 90 days | Acute congestive heart failure (diagnosed by a clinician) requiring hospitalization |
| Worsening heart failure | 0-90 days | Worsening to NYHA -class (New York Heart Association) III/IV or readmission for heart failure |
| Health related quality of life | 12 months | Assessed with self-reporting questionnaire |
| AKI (acute kidney injury) | 0-90 days | Rate of acute renal failure |
Countries
Finland
Contacts
Primary ContactJarmo M Gunn, adj. professor
Backup ContactTuija Vasankari, RN
Outcome results
None listed