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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01084044
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 3
• Duration (Months): 15.9
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Occlusive Disease	Drug: ulinastatin, saline solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ulinastatin	Drug: ulinastatin, saline solution; 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)
Active Comparator: saline solution	Drug: ulinastatin, saline solution; 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)
Placebo Comparator: Sugar pill	Drug: ulinastatin, saline solution; 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)

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT01084044
• Other Study ID Numbers: 4-2009-0420
• First Posted: Mar 10, 2010
• Last Update Posted: Feb 2, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Urinastatin

Study Results

No Results Posted as of Feb 2, 2012