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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01265680
Acronym
SHOT
Enrollment
600
Registered
2010-12-23
Start date
2012-02-29
Completion date
2013-01-31
Last updated
2013-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Transfusion

Keywords

Blood Transfusion, Heart surgery, Erythropoietin, HRE

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.

Interventions

DRUGErythropoietin

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

Sponsors

Cardiochirurgia E.H.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All comers

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
Use of allogenic blood transfusionsIn hospital stay (usually 5 to 8 days after operation)

Secondary

MeasureTime frame
Hemoglobin level on postoperative day four.Day 4 after operation

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026