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

NCT ID: NCT00944385

Last Updated: 2011-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Abnormal Aortic Valve

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ulinastatin

Administer with 30,000U /ulinastatin

Group Type EXPERIMENTAL

ulinastatin

Intervention Type DRUG

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

C group

administer normal saline

Group Type PLACEBO_COMPARATOR

ulinastatin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ulinastatin

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 40% below of output of left ventricle
* tricuspid valve failure from moderate to severe
* urgent surgery required
* infectious endocarditis
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Yonsei University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Severance Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Younglan Kwak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Severance Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

4-2009-0079

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lipoprotein(a) and Progression of Aortic Stenosis
NCT06648915 ACTIVE_NOT_RECRUITING