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

Phase 4

• Conditions: Aortic Aneurysm, Thoracic; Coronary Artery Disease; Aortic Valve Stenosis; Postoperative Complications; Mitral Valve Disease
• Interventions: Other: Physiological saline; Drug: Ferric carboxymaltose

• Registration Number: NCT03574311
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-06-29
• Study Start: 2018-10-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Physiological saline	Preoperative 100 ml saline as 30 minute infusion
Ferric carboxymaltose	Ferric carboxymaltose	Preoperative 1000 mg intravenous single dose as 30 minute infusion

Primary Outcome Measures

Name	Time	Method
Incidence of allogeneic blood transfusion and/or nosocomial infection	0-90 days	Composite of transfused red blood cell units and/or nosocomial infection

Secondary Outcome Measures

Name	Time	Method
Days on vasoactive drugs	0-90 days	Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.)
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
Mortality	0-90 days	All-cause mortality
Health related quality of life	12 months	Assessed with self-reporting questionnaire
Perioperative myocardial infarction	3 days	MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels
ICU/CCU days	0-90 days	Days in the ICU (intensive care unit) and/or CCU (cardiac care unit)
Length of stay	0-90 days	Days in hospital
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
Ventilator free days	0-90 days	Days not on ventilator (intubated or non-invasive ventilation)
AKI (acute kidney injury)	0-90 days	Rate of acute renal failure

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland