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Completed

NCT Number: NCT01265680

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

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

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Key information

Conditions

Blood Transfusion

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

European Hospital

Rome, 00149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All comers

Exclusion criteria

  • None

Treatment and study plan

Erythropoietin

Drug

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

Other names: Eprex

Primary outcomes

  1. Use of allogenic blood transfusions

    Time frame: In hospital stay (usually 5 to 8 days after operation)

Secondary outcomes

  1. Hemoglobin level on postoperative day four.

    Time frame: Day 4 after operation

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Registry information

Official study title

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

Acronym: SHOT

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 23, 2010
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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