NCT00944385

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

July 21, 2009

Last Update Submit

May 26, 2011

Conditions

Abnormal Aortic Valve

Study Arms (2)

ulinastatin

EXPERIMENTAL

Administer with 30,000U /ulinastatin

Drug: ulinastatin

C group

PLACEBO COMPARATOR

administer normal saline

Drug: ulinastatin

Interventions

ulinastatinDRUG

Administer 30000U/ulinastatin. Comparison of different dosages of drug.

C groupulinastatin

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

urinastatin

Study Officials

  • Younglan Kwak, MD, PhD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

KR(1)