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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944385
First Posted: July 23, 2009
Last Update Posted: May 27, 2011
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
According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.

Condition Intervention Phase
Abnormal Aortic Valve Drug: ulinastatin Phase 4

Study Type: Interventional
Official Title: Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

Further study details as provided by Yonsei University:

Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ulinastatin
Administer with 30,000U /ulinastatin
Drug: ulinastatin
Administer 30000U/ulinastatin. Comparison of different dosages of drug.
Placebo Comparator: C group
administer normal saline
Drug: ulinastatin
Administer 30000U/ulinastatin. Comparison of different dosages of drug.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 40% below of output of left ventricle
  • tricuspid valve failure from moderate to severe
  • urgent surgery required
  • infectious endocarditis
  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): NCT00944385


Locations
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Younglan Kwak, MD, PhD Severance Hospital
  More Information

Responsible Party: Young Lan Kwak/ Professor, MD, Severance Hospital
ClinicalTrials.gov Identifier: NCT00944385     History of Changes
Other Study ID Numbers: 4-2009-0079
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: May 27, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action