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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939978
First Posted: July 15, 2009
Last Update Posted: October 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  Purpose
The administration of rhEPO on the one day before cardiac surgery will be effective to decrease the bleeding due to the surgery.

Condition Intervention
Cardiac Surgery Drug: rhEPO

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Enrollment: 74
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Venoferrum Drug: rhEPO
recombinant human erythropoietin(rhEPO)
Placebo Comparator: saline Drug: rhEPO
recombinant human erythropoietin(rhEPO)

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Young-Lan Kwak/Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT00939978     History of Changes
Other Study ID Numbers: 4-2008-0427
First Submitted: July 14, 2009
First Posted: July 15, 2009
Last Update Posted: October 7, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics