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

NCT ID: NCT03574311

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-02
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ferric carboxymaltose

Preoperative 1000 mg intravenous single dose as 30 minute infusion

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

A single dose of drug or placebo is administered preoperatively to participants

Placebo

Preoperative 100 ml saline as 30 minute infusion

Group Type: PLACEBO_COMPARATOR

Physiological saline

Intervention Type: OTHER

Single infusion 100 ml physiological saline infusion preoperatively

Interventions

Ferric carboxymaltose

A single dose of drug or placebo is administered preoperatively to participants

Intervention Type: DRUG

Physiological saline

Single infusion 100 ml physiological saline infusion preoperatively

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vifor Pharma

INDUSTRY

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Turku University Hospital

Turku, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Jarmo M Gunn, adj. professor

Role: CONTACT

jarmo.gunn@tyks.fi

+35823130000

Tuija Vasankari, RN

Role: CONTACT

+35823130000

Facility Contacts

Jarmo M Gunn, PhD

Role: primary

jarmo.gunn@tyks.fi

+35823130548

Tuija Vasankari, RN

Role: backup

tuija.vasankari@tyks.fi

+35823130000

Other Identifiers

PREFER-CPB01

Identifier Type: -

Identifier Source: org_study_id