Blood Transfusion Clinical Trial
Official title:
Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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