Abnormal Aortic ValvePhase 4NCT00944385
Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
A Phase 4 study testing ulinastatin in people with Abnormal Aortic Valve, run by Yonsei University at 1 site in South Korea.
Trial summary
According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Abnormal Aortic Valve
- What is being tested?
- ulinastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40% below of output of left ventricle
- tricuspid valve failure from moderate to severe
- urgent surgery required
- infectious endocarditis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.
- Conditions
- Abnormal Aortic Valve
- Being tested
- ulinastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Administer 30000U/ulinastatin. Comparison of different dosages of drug.
| Study group | Role | What they receive |
|---|---|---|
| ulinastatin | Experimental | Administer with 30,000U /ulinastatin Receives: Drug: ulinastatin |
| C group | Placebo comparator | administer normal saline Receives: Drug: ulinastatin |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Aortic ValveStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Investigators
- Younglan Kwak, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944385
- Sponsor's protocol ID
- 4-2009-0079
- Status last verified
- May 2011
- First submitted
- 21 Jul 2009
- Last updated
- 27 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ulinastatin on Myocardial Protection and Blood Loss in Patients Undergoing Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT00944385
- Acronym / sponsor ID
- 4-2009-0079
- Conditions
- Abnormal Aortic Valve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 23 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to TEG (thromboelastography), as maximum amplitude is increased the amount of bleeding and transfusion and Cardiac enzyme is reduced by using ulinastatin.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ulinastatin | Experimental | Drug: ulinastatinAdminister with 30,000U /ulinastatin |
| C group | Placebo comparator | Drug: ulinastatinadminister normal saline |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 40% below of output of left ventricle
- tricuspid valve failure from moderate to severe
- urgent surgery required
- infectious endocarditis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinAdminister 30000U/ulinastatin. Comparison of different dosages of drug. | Drug | C group, ulinastatin |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
Related trials for Abnormal Aortic Valve
RecruitingPhase 3
LA-HCM Study : Rivaroxaban for Antithrombotic Prevention in Hypertrophic Cardiomyopathy Patients With Abnormal Left Atrial Strain.
Hypertrophic Cardiomyopathy (HCM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Younglan Kwak, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ulinastatin in people with Abnormal Aortic Valve, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2011.