Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.

Conditions
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Blood Transfusion

Intervention / Treatment
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* Drug: Erythropoietin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All comers Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythropoietin<br>80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital | Drug: Erythropoietin<br>* 80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.<br>* Other names: Eprex;|
| No Intervention: Control<br>No added administration other than our standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of allogenic blood transfusions |  | In hospital stay (usually 5 to 8 days after operation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin level on postoperative day four. |  | Day 4 after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Transfusion, Heart surgery, Erythropoietin, HRE