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

Not Applicable

Completed

• Conditions: Blood Transfusion
• Interventions: Drug: Erythropoietin

• Registration Number: NCT01265680
• Lead Sponsor: Cardiochirurgia E.H.

Brief 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

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.

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2012-02
• Primary Completion: 2012-11
• Study Completion: 2013-01
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-05
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• All comers

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erythropoietin	Erythropoietin	80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital

Primary Outcome Measures

Name	Time	Method
Use of allogenic blood transfusions	In hospital stay (usually 5 to 8 days after operation)

Secondary Outcome Measures

Name	Time	Method
Hemoglobin level on postoperative day four.	Day 4 after operation

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Italy