Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT02031289
First received: December 16, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

We are performing the above prospective randomized trial in 1'000 patients undergoing cardiac surgery. The study will answer the question of whether preoperative treatment of anemia or iron deficiency indeed improves transfusion needs (primary outcome) and important clinical outcomes (secondary outcome) in a large group of cardiac surgical patients. The list of inclusion and exclusion criteria was deliberately chosen short so that this patient group largely reflects today's clinical practice .

  • Trial with medical product

Condition Intervention Phase
Anemia
Iron Deficiency
Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Red blood cell (RBC) units transfused [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients without any RBC transfusions [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Length of stay in the intensive care unit (ICU) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Acute kidney failure [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    RIFLE I, AKIN 2

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Myocardial infarction, stroke, death

  • New atrial fibrillation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Infections [ Time Frame: 7 days ] [ Designated as safety issue: No ]

    Pneumonia, hospital acquired Deep Sternal Wound Infection

    Definition of infection: rise in inflammation markers after the initial postoperative period (acute phase reaction) and requires treatment and/ or prolongs days in hospital and/or microbiological confirmation of infection


  • Thrombotic and thromboembolic complications (90 days) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)

  • Length of stay (LOS) in the hospital [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • In hospital mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 30 day and 90-day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Costs (for blood products and pharmaceutical products related to transfusion and anemia management) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Comparison of costs for study medication versus costs for blood products and products related to transfusion

  • Perioperative Hb concentrations [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Calculated RBC and blood loss [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Comparison of the treatment and placebo groups with the natural comparison group [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Safety and tolerance of administered study drug and placebo [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    Comparison of all serious adverse events between study drug group and placebo group


Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anemia
Hb < 120 g/L in women, Hb < 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Treatment ) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3).

Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml NaCl over 30 min.

Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

Other Names:
  • Eprex
  • Ferinject
  • Vitarubin®-superconc
  • Acidum folicum
Active Comparator: Iron deficiency
ferritin < 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Treatment ) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3).

Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml NaCl over 30 min.

Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

Other Names:
  • Eprex
  • Ferinject
  • Vitarubin®-superconc
  • Acidum folicum
No Intervention: Natural comparison group
Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed

Detailed Description:

Anemic or iron deficiency patients are randomized into treatment and placebo groups. Treatment (see below) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3). The treatment will not be disclosed to the patient or the health care workers treating the patients during and after the operation.

Patients without anemia or iron deficiency will also be observed and the same postoperative measurements performed. They will serve as a natural comparison group.

Treatment:

Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml sodiumchloride (NaCl) over 30 min.

Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po.

The current transfusion and coagulation guidelines of the University Hospital of Zurich are followed in both groups identically. Postoperatively on the regular ward a Hb transfusion trigger of 80 g/L is applied

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients undergoing valve- and/or coronary bypass surgery
  • Signed patient informed consent
  • Only patients will be enrolled who won't have an emergency surgery on the same day

Exclusion criteria:

  • Participation in another clinical trial within the last 4 weeks prior to enrollment
  • Addiction or other disease that did not allow the patient to assess the nature, scope and possible consequences of the clinical tial
  • Patients who do not sign the consent form or may not fully understand from inadequate knowledge of German.
  • Patients who have not reached the age of legal majority
  • Pregnant or lactating women
  • Jehovah's Witnesses
  • Patients with endocarditis
  • Existing allergy or intolerance to ferric carboxymaltose or mannitol
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031289

Contacts
Contact: Felix Schoenrath, MD felix.schoenrath@usz.ch
Contact: Donat R Spahn, Prof MD donat.spahn@usz.ch

Locations
Switzerland
University Hospital Zurich, Institute of Anaesthesiology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Donat R Spahn, Prof MD University Hospital Zurich, Institute of Anaesthesiology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02031289     History of Changes
Other Study ID Numbers: IFA2012/IDCS
Study First Received: December 16, 2013
Last Updated: March 3, 2014
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Anemia
Iron deficiency
Cardiac surgery
Perioperative Care

Additional relevant MeSH terms:
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Epoetin Alfa
Folic Acid
Hydroxocobalamin
Ferric Compounds
Vitamin B Complex
Vitamin B 12
Iron
Vitamins
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on July 22, 2014