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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erythropoietin | Experimental | 80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital |
|
| Control | No Intervention | No added administration other than our standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erythropoietin | Drug | 80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use of allogenic blood transfusions | In hospital stay (usually 5 to 8 days after operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin level on postoperative day four. | Day 4 after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Hospital | Rome | 00149 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39301879 | Derived | Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2. |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |