An interventional study of Erythropoietin in Blood Transfusion, sponsored by Cardiochirurgia E.H.. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2013-04-08.
Sponsored by Cardiochirurgia E.H. · Not applicable, Interventional, and Treatment
All patients operated on at the European Hospital Heart surgery Division will be randomized to either single dose 80.000 UI of Human Recombinant Erythropoietin and intravenous iron or control.
Primary end point is the amount of transfused blood. Secondary end point is the Hemoglobin level in the patient on postoperative day four.
Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well
Growing evidence points out blood transfusion as a major determinant in medium and long term prognosis as regarding heart surgery population. Moreover blood has become a scarce resource, thus often delaying intervention due to lack of availability.
Previous studies at our Hospital have shown that high dose Human Recombinant Erythropoietin (HRE)effectively spares transfusions even when administered two days before surgery. The previous protocol was fragmented into 5 administration which proved to be unpractical even if effective.
After multidisciplinal discussion with nephrologists and transfusionists a new protocol was established: 80.000 UI in a single dose at time of arrival at the hospital. There are no exclusion criteria planned.
Our primary end point is the amount of transfused blood. Our secondary end point is the Hemoglobin level in the patient on postoperative day four.
Ancillary analysis regarding safety at 45 days and cost effectiveness are planned as well.
Cardiochirurgia E.H. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
Drug: Erythropoietin
No added administration other than our standard of care.
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.
Also known as: Eprex
Use of allogenic blood transfusions
Time frame: In hospital stay (usually 5 to 8 days after operation)
Hemoglobin level on postoperative day four.
Time frame: Day 4 after operation
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Cardiochirurgia E.H.