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

Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939978
• Other study ID #: 4-2008-0427
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: October 6, 2010
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2010
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• rhEPO
recombinant human erythropoietin(rhEPO)

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of,