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Completed

NCT Number: NCT02031289

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

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 .

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Institute of Anaesthesiology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Drug

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

Primary outcomes

  1. Red blood cell (RBC) units transfused

    Time frame: 7 days

Secondary outcomes

  1. Percentage of patients without any RBC transfusions

    Time frame: 90 days

  2. Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)

    Time frame: 90 days

  3. Length of stay in the intensive care unit (ICU)

    Time frame: 90 days

  4. Duration of mechanical ventilation

    Time frame: 90 days

  5. Acute kidney failure

    Time frame: 7 days

    RIFLE I, AKIN 2

  6. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: 90 days

    Myocardial infarction, stroke, death

  7. New atrial fibrillation

    Time frame: 90 days

  8. Infections

    Time frame: 7 days

    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

  9. Thrombotic and thromboembolic complications (90 days)

    Time frame: 90 days

    clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)

  10. Length of stay (LOS) in the hospital

    Time frame: 90 days

  11. Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)

    Time frame: 90 days

  12. In hospital mortality

    Time frame: 90 days

  13. 30 day and 90-day mortality

    Time frame: 90 days

  14. Costs (for blood products and pharmaceutical products related to transfusion and anemia management)

    Time frame: 90 days

    Comparison of costs for study medication versus costs for blood products and products related to transfusion

  15. Perioperative Hb concentrations

    Time frame: 90 days

  16. Calculated RBC and blood loss

    Time frame: 90 days

  17. Comparison of the treatment and placebo groups with the natural comparison group

    Time frame: 90 days

  18. Safety and tolerance of administered study drug and placebo

    Time frame: 90 days

    Comparison of all serious adverse events between study drug group and placebo group

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jan 9, 2014
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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