Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
Phase 4
Completed
- Conditions
- Coronary Artery Occlusive Disease
- Interventions
- Drug: ulinastatin, saline solution
- Registration Number
- NCT01084044
- Lead Sponsor
- Yonsei University
- Brief Summary
Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description saline solution ulinastatin, saline solution - Sugar pill ulinastatin, saline solution - ulinastatin ulinastatin, saline solution -
- Primary Outcome Measures
Name Time Method ulinastatin 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Severance Hospital, Yonsei University College of Medicine
🇰🇷Seoul, Korea, Republic of