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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier:
NCT01265680
First received: December 22, 2010
Last updated: April 5, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Cardiochirurgia E.H.:

Primary Outcome Measures:
  • Use of allogenic blood transfusions [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin level on postoperative day four. [ Time Frame: Day 4 after operation ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All comers

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01265680

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

No publications provided

Responsible Party: Luca Weltert, Project Leader Luca Weltert, Cardiochirurgia E.H.
ClinicalTrials.gov Identifier: NCT01265680     History of Changes
Other Study ID Numbers: 00-05
Study First Received: December 22, 2010
Last Updated: April 5, 2013
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014