Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery

Coronary Artery Disease Clinical Trial

— PREFER-CABG  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03574311
• Other study ID #: PREFER-CPB01
• Status: Recruiting
• Phase: Phase 4
• Start date: October 2, 2018
• Est. completion date: December 2023

Study information

• Verified date: April 2021
• Source: Turku University Hospital
• Contact: Jarmo M Gunn, adj. professor
• Phone: +35823130000
• Email: jarmo.gunn[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Aortic Valve Stenosis
• Coronary Artery Disease
• Mitral Valve Disease
• Postoperative Complications

Intervention

Drug:
• Ferric carboxymaltose
A single dose of drug or placebo is administered preoperatively to participants

Other:
• Physiological saline
Single infusion 100 ml physiological saline infusion preoperatively

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Vifor Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of allogeneic blood transfusion and/or nosocomial infection	Composite of transfused red blood cell units and/or nosocomial infection	0-90 days
Secondary	Mortality	All-cause mortality	0-90 days
Secondary	ICU/CCU days	Days in the ICU (intensive care unit) and/or CCU (cardiac care unit)	0-90 days
Secondary	Perioperative myocardial infarction	MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels	3 days
Secondary	Length of stay	Days in hospital	0-90 days
Secondary	Days on vasoactive drugs	Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.)	0-90 days
Secondary	Ventilator free days	Days not on ventilator (intubated or non-invasive ventilation)	0-90 days
Secondary	AKI (acute kidney injury)	Rate of acute renal failure	0-90 days
Secondary	New onset atrial fibrillation (AF) or flutter	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	0-90 days
Secondary	Acute heart failure	Acute congestive heart failure (diagnosed by a clinician) requiring hospitalization	90 days
Secondary	Worsening heart failure	Worsening to NYHA -class (New York Heart Association) III/IV or readmission for heart failure	0-90 days
Secondary	Health related quality of life	Assessed with self-reporting questionnaire	12 months