Blood Sparing Strategies: Single Shot High Dose Erythropoietin Two Days Before Heart Surgery (SHOT)
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Purpose
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 | Intervention |
|---|---|
|
Blood Transfusion |
Drug: Erythropoietin |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 600 |
| Study Start Date: | February 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
|
Drug: Erythropoietin
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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- All comers
Exclusion Criteria:
- None
Contacts and Locations More Information
No publications provided
| Responsible Party: | Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H. |
| ClinicalTrials.gov Identifier: | NCT01265680 History of Changes |
| Other Study ID Numbers: | 00-05 |
| Study First Received: | December 22, 2010 |
| Last Updated: | April 5, 2013 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Cardiochirurgia E.H.:
|
Blood Transfusion Heart surgery Erythropoietin HRE |
Additional relevant MeSH terms:
|
Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013