Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery (SHOT)
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.|
- Use of allogenic blood transfusions [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ] [ Designated as safety issue: No ]
- Hemoglobin level on postoperative day four. [ Time Frame: Day 4 after operation ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.
Other Name: Eprex
No Intervention: Control
No added administration other than our standard of care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265680
|Rome, Italy, 00149|