NCT01265680

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

9 months

First QC Date

December 22, 2010

Last Update Submit

April 5, 2013

Conditions

Blood Transfusion

Keywords

Blood TransfusionHeart surgeryErythropoietinHRE

Outcome Measures

Primary Outcomes (1)

  • Use of allogenic blood transfusions

    In hospital stay (usually 5 to 8 days after operation)

Secondary Outcomes (1)

  • Hemoglobin level on postoperative day four.

    Day 4 after operation

Study Arms (2)

Erythropoietin

EXPERIMENTAL

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

Drug: Erythropoietin

Control

NO INTERVENTION

No added administration other than our standard of care.

Interventions

ErythropoietinDRUG

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

Also known as: Eprex
Erythropoietin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All comers

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Rome, 00149, Italy

Location

Related Publications (1)

  • Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

    PMID: 39301879DERIVED

MeSH Terms

Interventions

ErythropoietinEpoetin Alfa

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader Luca Weltert

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 23, 2010

Study Start

February 1, 2012

Primary Completion

November 1, 2012

Study Completion

January 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

IT(1)