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

Information source: Cardiochirurgia E.H.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Blood Transfusion

Intervention: Erythropoietin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Cardiochirurgia E.H.

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Use of allogenic blood transfusions

Secondary outcome: Hemoglobin level on postoperative day four.

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All comers

Exclusion Criteria:

- None

Locations and Contacts

European Hospital, Rome 00149, Italy
Additional Information

Starting date: February 2012
Last updated: April 5, 2013

Page last updated: August 23, 2015

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