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

Yonsei University80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Coronary Artery Occlusive Disease

Interventions

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)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 24 hours after surgery

Data from ClinicalTrials.gov

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