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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT00944385
First received: July 21, 2009
Last updated: May 26, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Young Lan Kwak/ Professor, MD, Severance Hospital
ClinicalTrials.gov Identifier: NCT00944385     History of Changes
Other Study ID Numbers: 4-2009-0079
Study First Received: July 21, 2009
Last Updated: May 26, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on October 23, 2014