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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00939978
First received: July 14, 2009
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  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:

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

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939978

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

No publications provided

Responsible Party: Young-Lan Kwak/Professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT00939978     History of Changes
Other Study ID Numbers: 4-2008-0427
Study First Received: July 14, 2009
Last Updated: October 6, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013