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

July 21, 2009
May 26, 2011
June 2009
April 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00944385 on ClinicalTrials.gov Archive Site
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Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement

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

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Interventional
Phase 4
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Abnormal Aortic Valve
Drug: ulinastatin
Administer 30000U/ulinastatin. Comparison of different dosages of drug.
  • Experimental: ulinastatin
    Administer with 30,000U /ulinastatin
    Intervention: Drug: ulinastatin
  • Placebo Comparator: C group
    administer normal saline
    Intervention: Drug: ulinastatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 40% below of output of left ventricle
  • tricuspid valve failure from moderate to severe
  • urgent surgery required
  • infectious endocarditis
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00944385
4-2009-0079
Not Provided
Young Lan Kwak/ Professor, MD, Severance Hospital
Yonsei University
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Principal Investigator: Younglan Kwak, MD, PhD Severance Hospital
Yonsei University
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP