Anemia | Impact of Preoperative Treatment of Anemia and Iron Deficiency in Cardiac Surgery on Outcome.
Anemia research study
What is the primary objective of this study?
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
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic AcidTreatment ) 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
AnemiaHb < 120 g/L in women, Hb < 130 g/L in men Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Iron deficiencyferritin < 100 µg/l Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid
Natural comparison groupPatients without anemia or iron deficiency will be observed and the same postoperative measurements performed
Start Date: December 2013
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: Red blood cell (RBC) units transfused
Secondary Outcome: Percentage of patients without any RBC transfusions
Study sponsors, principal investigator, and references
Principal Investigator: Donat R Spahn, Prof MD
Lead Sponsor: University of Zurich