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

Blood Transfusion Clinical Trial

— SHOT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265680
• Other study ID #: 00-05
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: April 5, 2013
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All comers

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Blood Transfusion

Intervention

Drug:
• Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of allogenic blood transfusions		In hospital stay (usually 5 to 8 days after operation)	No
Secondary	Hemoglobin level on postoperative day four.		Day 4 after operation	No