Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery

Yonsei University

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Occlusive Disease

Treatments: Drug: ulinastatin, saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01084044

4-2009-0420

Details and patient eligibility

About

Ulinastatin reduce the amount of bleeding and fibrinolysis in high risk patients undergoing off-pump coronary bypass surgery (OPCAB).

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

ulinastatin

Experimental group

Treatment:

Drug: ulinastatin, saline solution

saline solution

Active Comparator group

Treatment:

Drug: ulinastatin, saline solution

Sugar pill

Placebo Comparator group

Treatment:

Drug: ulinastatin, saline solution