Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

Abnormal Aortic Valve Clinical Trial

Official title:

Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944385
• Other study ID #: 4-2009-0079
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2009
• Last updated: May 26, 2011
• Start date: June 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• 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

According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• 40% below of output of left ventricle

• tricuspid valve failure from moderate to severe

• urgent surgery required

• infectious endocarditis

Study Design

N/A

Related Conditions & MeSH terms

• Abnormal Aortic Valve

Intervention

Drug:
• ulinastatin
Administer 30000U/ulinastatin. Comparison of different dosages of drug.

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,