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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Anemia; Iron Deficiency

Treatments: Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02031289

IFA2012/IDCS

Details and patient eligibility

About

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

Full 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

Enrollment: 1,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,003 participants in 3 patient groups

Anemia

Active Comparator group

Description:

Hb \< 120 g/L in women, Hb \< 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Treatment:

Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Iron deficiency

Active Comparator group

Description:

ferritin \< 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Treatment:

Drug: Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid

Natural comparison group

No Intervention group

Description:

Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed