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

December 22, 2010
April 5, 2013
February 2012
November 2012   (final data collection date for primary outcome measure)
Use of allogenic blood transfusions [ Time Frame: In hospital stay (usually 5 to 8 days after operation) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01265680 on ClinicalTrials.gov Archive Site
Hemoglobin level on postoperative day four. [ Time Frame: Day 4 after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Blood Transfusion
Drug: Erythropoietin
80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.
Other Name: Eprex
  • Experimental: Erythropoietin
    80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital
    Intervention: Drug: Erythropoietin
  • No Intervention: Control
    No added administration other than our standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All comers

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01265680
00-05
Yes
Luca Weltert, Cardiochirurgia E.H.
Cardiochirurgia E.H.
Not Provided
Not Provided
Cardiochirurgia E.H.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP