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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT00944385
Collaborator
(none)
1
Location
2
Arms
22
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Official Title:
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Apr 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 40% below of output of left ventricle

    • tricuspid valve failure from moderate to severe

    • urgent surgery required

    • infectious endocarditis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance Hospital Seoul Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Younglan Kwak, MD, PhD, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00944385
    Other Study ID Numbers:
    • 4-2009-0079
    First Posted:
    Jul 23, 2009
    Last Update Posted:
    May 27, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Hemorrhage
    Urinastatin

    Study Results

    No Results Posted as of May 27, 2011