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

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ClinicalTrials.gov Identifier: NCT00939978
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : October 7, 2010
Sponsor:
Information provided by:
Yonsei University

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

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: rhEPO Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Study Start Date : April 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Venoferrum Drug: rhEPO
recombinant human erythropoietin(rhEPO)
Placebo Comparator: saline Drug: rhEPO
recombinant human erythropoietin(rhEPO)




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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00939978


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University

Responsible Party: Young-Lan Kwak/Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT00939978     History of Changes
Other Study ID Numbers: 4-2008-0427
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics