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

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ClinicalTrials.gov Identifier: NCT01265680
Recruitment Status : Completed
First Posted : December 23, 2010
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, 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


Condition or disease Intervention/treatment Phase
Blood Transfusion Drug: Erythropoietin Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
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.
Study Start Date : February 2012
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



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

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


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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:


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.

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 Posted: December 23, 2010    Key Record Dates
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