Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery (PREFER-CABG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03574311
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Vifor Pharma
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Postoperative Complications Aortic Valve Stenosis Mitral Valve Disease Aortic Aneurysm, Thoracic Drug: Ferric carboxymaltose Other: Physiological saline Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled 1:1
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blinding, study drug administration by separate staff blinded from participant and investigators
Primary Purpose: Prevention
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
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Ferric carboxymaltose
Preoperative 1000 mg intravenous single dose as 30 minute infusion
Drug: Ferric carboxymaltose
A single dose of drug or placebo is administered preoperatively to participants

Placebo Comparator: Placebo
Preoperative 100 ml saline as 30 minute infusion
Other: Physiological saline
Single infusion 100 ml physiological saline infusion preoperatively




Primary Outcome Measures :
  1. Incidence of allogeneic blood transfusion and/or nosocomial infection [ Time Frame: 0-90 days ]
    Composite of transfused red blood cell units and/or nosocomial infection


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 0-90 days ]
    All-cause mortality

  2. ICU/CCU days [ Time Frame: 0-90 days ]
    Days in the ICU (intensive care unit) and/or CCU (cardiac care unit)

  3. Perioperative myocardial infarction [ Time Frame: 3 days ]
    MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels

  4. Length of stay [ Time Frame: 0-90 days ]
    Days in hospital

  5. Days on vasoactive drugs [ Time Frame: 0-90 days ]
    Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.)

  6. Ventilator free days [ Time Frame: 0-90 days ]
    Days not on ventilator (intubated or non-invasive ventilation)

  7. AKI (acute kidney injury) [ Time Frame: 0-90 days ]
    Rate of acute renal failure

  8. New onset atrial fibrillation (AF) or flutter [ Time Frame: 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

  9. Acute heart failure [ Time Frame: 90 days ]
    Acute congestive heart failure (diagnosed by a clinician) requiring hospitalization

  10. Worsening heart failure [ Time Frame: 0-90 days ]
    Worsening to NYHA -class (New York Heart Association) III/IV or readmission for heart failure

  11. Health related quality of life [ Time Frame: 12 months ]
    Assessed with self-reporting questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574311


Contacts
Layout table for location contacts
Contact: Jarmo M Gunn, adj. professor +35823130000 jarmo.gunn@tyks.fi
Contact: Tuija Vasankari, RN +35823130000

Locations
Layout table for location information
Finland
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Jarmo M Gunn, PhD    +35823130548    jarmo.gunn@tyks.fi   
Contact: Tuija Vasankari, RN    +35823130000    tuija.vasankari@tyks.fi   
Sponsors and Collaborators
Turku University Hospital
Vifor Pharma
Layout table for additonal information
Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03574311    
Other Study ID Numbers: PREFER-CPB01
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Turku University Hospital:
CABG
cardiac surgery
blood transfusion
intravenous iron
postoperative infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Aneurysm
Aortic Aneurysm
Aortic Valve Stenosis
Aortic Aneurysm, Thoracic
Postoperative Complications
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aortic Diseases
Pathologic Processes
Heart Valve Diseases
Ventricular Outflow Obstruction