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

Primary Purpose

Abnormal Aortic Valve

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ulinastatin
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Abnormal Aortic Valve

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ulinastatin

C group

Arm Description

Administer with 30,000U /ulinastatin

administer normal saline

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 21, 2009
Last Updated
May 26, 2011
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT00944385
Brief Title
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
Official Title
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Aortic Valve

7. Study Design

Study Phase
Phase 4

8. Arms, Groups, and Interventions

Arm Title
ulinastatin
Arm Type
Experimental
Arm Description
Administer with 30,000U /ulinastatin
Arm Title
C group
Arm Type
Placebo Comparator
Arm Description
administer normal saline
Intervention Type
Drug
Intervention Name(s)
ulinastatin
Intervention Description
Administer 30000U/ulinastatin. Comparison of different dosages of drug.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 40% below of output of left ventricle tricuspid valve failure from moderate to severe urgent surgery required infectious endocarditis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Younglan Kwak, MD, PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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

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