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
  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

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 April 17, 2014