Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery (SHOT)
|ClinicalTrials.gov Identifier: NCT01265680|
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : April 8, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Blood Transfusion||Drug: Erythropoietin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||January 2013|
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.
- Use of allogenic blood transfusions [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ]
- Hemoglobin level on postoperative day four. [ Time Frame: Day 4 after operation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265680
|Rome, Italy, 00149|