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

NCT01265680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2013-04-08

No results posted yet for this study

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

Conditions

  • Blood Transfusion

Interventions

DRUG

Erythropoietin

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

Sponsors & Collaborators

  • Cardiochirurgia E.H.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01265680 on ClinicalTrials.gov