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Trial record 36 of 380 for:    FERRIC CATION

Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective Coronary Artery Bypass Grafting (PREFER-CABG)

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ClinicalTrials.gov Identifier: NCT03574311
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : October 8, 2018
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 isolated coronary artery bypass grafting. 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 Drug: Ferric carboxymaltose Other: Physiological saline Phase 4

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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 Coronary Artery Bypass Grafting
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



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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 (male of female) presenting with coronary artery disease (CAD) according to the definition by ESC guidelines for the diagnosis of CAD.
  2. Coronary bypass surgery considered as the best appropriate revascularization strategy according to the current ESC guidelines for the management of CAD:

    1. significant three vessel disease
    2. left main disease ± single, two or three vessel disease
    3. two-vessel disease with proximal LAD
  3. Written informed consent signed before any study-specific procedure

Exclusion Criteria:

  1. Age < 18 years
  2. Patients requiring urgent, emergency or salvage CABG (i.e. patients with acute coronary syndromes)
  3. Need for additional heart surgery other than CABG
  4. Treatment with another investigational product 30 days prior to randomization
  5. Moribund patient not expected to survive 12 months after surgery
  6. Active malignant disease with a short life expectancy, e.g. malignant cancer
  7. Severe chronic obstructive pulmonary disease (COPD) requiring home mechanical ventilation (noninvasive ventilation or via tracheotomy) except for Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BIPAP) used solely for central or obstructive sleep-apnea.
  8. Ongoing oral or parenteral iron medication at the time of randomization
  9. Renal dialysis therapy for chronic renal failure, or severe renal impairment (eGFR<30ml/min)
  10. 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.
  11. Porphyria cutanea tarda.
  12. Liver failure (Child-Pugh class B or C).
  13. Iron or haemoglobin metabolism or synthesis disorders (e.g. haemochromatosis, thalassemia)
  14. Pregnancy.
  15. Body weight less than 50kg.
  16. Any other condition or therapy, which in the Investigator's opinion would make the subject unsuitable for this study and will not allow active participation for the full planned study period

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
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Contact: Jarmo M Gunn, adj. professor +35823130000 jarmo.gunn@tyks.fi
Contact: Tuija Vasankari, RN +35823130000

Locations
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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

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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT03574311     History of Changes
Other Study ID Numbers: PREFER-CABG01
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ferric Compounds
Coronary Artery Disease
Postoperative Complications
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Hematinics