Clinical trial NCT02031289: Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
Official title: Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Iron Deficiency
Keywords: Anemia
Iron deficiency
Cardiac surgery
Perioperative Care
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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 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

Primary outcomes:
measure: Red blood cell (RBC) units transfused
timeFrame: 7 days
Secondary outcomes:
measure: Percentage of patients without any RBC transfusions
timeFrame: 90 days
measure: Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets)
timeFrame: 90 days
measure: Length of stay in the intensive care unit (ICU)
timeFrame: 90 days
measure: Duration of mechanical ventilation
timeFrame: 90 days
measure: Acute kidney failure
timeFrame: 7 days
measure: Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 90 days
measure: New atrial fibrillation
timeFrame: 90 days
measure: Infections
timeFrame: 7 days
measure: Thrombotic and thromboembolic complications (90 days)
timeFrame: 90 days
measure: Length of stay (LOS) in the hospital
timeFrame: 90 days
measure: Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs)
timeFrame: 90 days
measure: In hospital mortality
timeFrame: 90 days
measure: 30 day and 90-day mortality
timeFrame: 90 days
measure: Costs (for blood products and pharmaceutical products related to transfusion and anemia management)
timeFrame: 90 days
measure: Perioperative Hb concentrations
timeFrame: 90 days
measure: Calculated RBC and blood loss
timeFrame: 90 days
measure: Comparison of the treatment and placebo groups with the natural comparison group
timeFrame: 90 days
measure: Safety and tolerance of administered study drug and placebo
timeFrame: 90 days
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Institute of Anaesthesiology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Institute of Anaesthesiology
name: Donat R Spahn, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossler J, Schoenrath F, Seifert B, Kaserer A, Spahn GH, Falk V, Spahn DR. Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study. Br J Anaesth. 2020 Jan;124(1):25-34. doi: 10.1016/j.bja.2019.09.016. Epub 2019 Oct 24.
citation: Spahn DR, Schoenrath F, Spahn GH, Seifert B, Stein P, Theusinger OM, Kaserer A, Hegemann I, Hofmann A, Maisano F, Falk V. Effect of ultra-short-term treatment of patients with iron deficiency or anaemia undergoing cardiac surgery: a prospective randomised trial. Lancet. 2019 Jun 1;393(10187):2201-2212. doi: 10.1016/S0140-6736(18)32555-8. Epub 2019 Apr 26.