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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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