Coronary Artery Occlusive DiseasePhase 4NCT01084044
Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
A Phase 4 study testing ulinastatin, saline solution in people with Coronary Artery Occlusive Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Occlusive Disease
- What is being tested?
- ulinastatin, saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighty high risk patients undergoing OPCAB (High risk patients: Euro score ≥ 6 , acute coronary syndrome, preoperative CK-MB increased over 5 times than normal value and high sensitivity CRP ≥2.0)
Who cannot join
- The patients who receive additional operations, the patients who don't agree to participate in this trial, the patients who has a past hypersensitive experience on Ulinastatin
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).
- Conditions
- Coronary Artery Occlusive Disease
- Being tested
- ulinastatin, saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatin, saline solutionDrug
the ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40)
| Study group | Role | What they receive |
|---|---|---|
| ulinastatin | Experimental | Not described Receives: Drug: ulinastatin, saline solution |
| saline solution | Active comparator | Not described Receives: Drug: ulinastatin, saline solution |
| Sugar pill | Placebo comparator | Not described Receives: Drug: ulinastatin, saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
ulinastatin
The purpose of this study was to evaluate whether ulinastatin significantly affect on coagulation and blood loss in high risk patients undergoing off-pump coronary bypass surgery (OPCAB). - thrombin-antithrombin complex (TAT), prothrombin fragment 1+2(F1,2), platelet factor-4 (PF-4) , hemoglobin, platelet count, white blood cell differential count, prothrombin time (PT), partial prothrombin time (aPTT), amount of blood loss, transfusion, urine output and intravenous fluid input
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Occlusive DiseaseStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084044
- Sponsor's protocol ID
- 4-2009-0420
- Status last verified
- Jan 2012
- First submitted
- 8 Mar 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT01084044
- Acronym / sponsor ID
- 4-2009-0420
- Conditions
- Coronary Artery Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Mar 2010 (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.
Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ulinastatin | Experimental | Drug: ulinastatin, saline solution |
| saline solution | Active comparator | Drug: ulinastatin, saline solution |
| Sugar pill | Placebo comparator | Drug: ulinastatin, saline solution |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eighty high risk patients undergoing OPCAB (High risk patients: Euro score ≥ 6 , acute coronary syndrome, preoperative CK-MB increased over 5 times than normal value and high sensitivity CRP ≥2.0)
Key exclusion criteria (1 listed)
- The patients who receive additional operations, the patients who don't agree to participate in this trial, the patients who has a past hypersensitive experience on Ulinastatin
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 |
|---|---|---|
| ulinastatin, saline solutionthe ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40) | Drug | Sugar pill, saline solution, ulinastatin |
Primary outcome
ulinastatin
Time frame: 24 hours after surgery
The purpose of this study was to evaluate whether ulinastatin significantly affect on coagulation and blood loss in high risk patients undergoing off-pump coronary bypass surgery (OPCAB). - thrombin-antithrombin complex (TAT), prothrombin fragment 1+2(F1,2), platelet factor-4 (PF-4) , hemoglobin, platelet count, white blood cell differential count, prothrombin time (PT), partial prothrombin time (aPTT), amount of blood loss, transfusion, urine output and intravenous fluid input
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 2 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, saline solution in people with Coronary Artery Occlusive Disease, 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 1 inclusion and 1 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 2 Feb 2012. 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.
What does the primary outcome measure?
ulinastatin (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
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 2 Feb 2012.