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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01265680
First Posted: December 23, 2010
Last Update Posted: April 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
  Purpose

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


Condition Intervention
Blood Transfusion Drug: Erythropoietin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single High Dose Erythropoietin Obviates Transfusions: an Independent, Blinded, Prospective Randomized Study in Heart Surgery Population.

Resource links provided by NLM:


Further study details as provided by Luca Weltert, Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Use of allogenic blood transfusions [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ]

Secondary Outcome Measures:
  • Hemoglobin level on postoperative day four. [ Time Frame: Day 4 after operation ]

Enrollment: 600
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
Drug: Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.
Other Name: Eprex
No Intervention: Control
No added administration other than our standard of care.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All comers

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265680


Locations
Italy
European Hospital
Rome, Italy, 00149
Sponsors and Collaborators
Cardiochirurgia E.H.
  More Information

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01265680     History of Changes
Other Study ID Numbers: 00-05
First Submitted: December 22, 2010
First Posted: December 23, 2010
Last Update Posted: April 8, 2013
Last Verified: April 2013

Keywords provided by Luca Weltert, Cardiochirurgia E.H.:
Blood Transfusion
Heart surgery
Erythropoietin
HRE

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics