University Hospital Zurich, Institute of Anaesthesiology
Zurich, Canton of Zurich, 8091, Switzerland
NCT Number: NCT02031289
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
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Zurich, Canton of Zurich, 8091, Switzerland
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 7 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 7 days
RIFLE I, AKIN 2
Time frame: 90 days
Myocardial infarction, stroke, death
Time frame: 90 days
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
Time frame: 90 days
clinical symptoms and evidence of thrombosis/ embolism in one of the following imaging methods (ultrasound, CT-scan)
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Comparison of costs for study medication versus costs for blood products and products related to transfusion
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Time frame: 90 days
Comparison of all serious adverse events between study drug group and placebo group
University of Zurich
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT01052779
Anemia, Anemia, Hypochromic
Tempe, Arizona, United States
View Trial DetailsNCT02222805
Anemia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Kathmandu, Nepal
View Trial DetailsNCT04632771
Anemia, Avitaminosis
Accra, Ghana
View Trial DetailsNCT01665378
Anemia, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hành Phố Thái Nguyên, Thái Nguyên, Vietnam
View Trial Details