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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 .
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anemia | Active Comparator | Hb < 120 g/L in women, Hb < 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid |
|
| Iron deficiency | Active Comparator | ferritin < 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid |
|
| Natural comparison group | No Intervention | Patients without anemia or iron deficiency will be observed and the same postoperative measurements performed |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Red blood cell (RBC) units transfused | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without any RBC transfusions | 90 days | |
| Combined allogeneic transfusions (RBC, FFP( fresh frozen plasma), platelets) | 90 days | |
| Length of stay in the intensive care unit (ICU) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donat R Spahn, Prof MD | University Hospital Zurich, Institute of Anaesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Institute of Anaesthesiology | Zurich | Canton of Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31668348 | Derived | 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. | |
| 31036337 | Derived | 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. |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D000068817 | Epoetin Alfa |
| C522335 | ferric carboxymaltose |
| D002955 | Leucovorin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
|
| 90 days |
| Duration of mechanical ventilation | 90 days |
| Acute kidney failure | RIFLE I, AKIN 2 | 7 days |
| Major Adverse Cardiac and Cerebrovascular Events (MACCE) | Myocardial infarction, stroke, death | 90 days |
| New atrial fibrillation | 90 days |
| Infections | 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 | 7 days |
| Thrombotic and thromboembolic complications (90 days) | clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan) | 90 days |
| Length of stay (LOS) in the hospital | 90 days |
| Length of hospital stay (in comparison to median LOS published for relevant Swiss-DRGs) | 90 days |
| In hospital mortality | 90 days |
| 30 day and 90-day mortality | 90 days |
| Costs (for blood products and pharmaceutical products related to transfusion and anemia management) | Comparison of costs for study medication versus costs for blood products and products related to transfusion | 90 days |
| Perioperative Hb concentrations | 90 days |
| Calculated RBC and blood loss | 90 days |
| Comparison of the treatment and placebo groups with the natural comparison group | 90 days |
| Safety and tolerance of administered study drug and placebo | Comparison of all serious adverse events between study drug group and placebo group | 90 days |
| D009750 | Nutritional and Metabolic Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |