Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.
Overview
- Phase
- Not Applicable
- Intervention
- Erythropoietin
- Conditions
- Blood Transfusion
- Sponsor
- Cardiochirurgia E.H.
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Use of allogenic blood transfusions
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Luca Weltert
Project Leader Luca Weltert
Cardiochirurgia E.H.
Eligibility Criteria
Inclusion Criteria
- •All comers
Exclusion Criteria
- Not provided
Arms & Interventions
Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
Intervention: Erythropoietin
Outcomes
Primary Outcomes
Use of allogenic blood transfusions
Time Frame: In hospital stay (usually 5 to 8 days after operation)
Secondary Outcomes
- Hemoglobin level on postoperative day four.(Day 4 after operation)