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Effect of Preoperative Recombinant Human Erythropoietin on Transfusion Risk in Valvular Heart Surgery

NCT ID: NCT00939978

Last Updated: 2010-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.

Detailed Description

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Conditions

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Cardiac Surgery

Study Groups

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Venoferrum

Group Type ACTIVE_COMPARATOR

rhEPO

Intervention Type DRUG

recombinant human erythropoietin(rhEPO)

saline

Group Type PLACEBO_COMPARATOR

rhEPO

Intervention Type DRUG

recombinant human erythropoietin(rhEPO)

Interventions

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rhEPO

recombinant human erythropoietin(rhEPO)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The 90 patients who are planned to have the heart surgery during this study period.(minimum age 20)

Exclusion Criteria

* Uncontrolled hypertension(diastolic blood pressure(DBP)\>100 mmHg), Hct \> 45%, Plt. count)\>450,000
* There are no history of seizure, thrombus, cancer, acute hepatitis, alcoholism, peripheral blood vessel disease, pure red blood cell dysfunction, liver function failure, chronic multiple arthritis.
* No pregnancy, acute hyper parathyroidism.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Severance Hospital

Locations

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Severance hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2008-0427

Identifier Type: -

Identifier Source: org_study_id