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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01084044

First received: March 8, 2010

Last updated: January 31, 2012

Last verified: January 2012

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Effects of Ulinastatin on Coagulation in High Risk Patients Undergoing Off Pump Coronary Artery Bypass Graft Surgery

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

ulinastatin [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
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

Enrollment:	80
Study Start Date:	January 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084044

Locations

Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of

Sponsors and Collaborators

Yonsei University

More Information

No publications provided

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01084044 History of Changes
Other Study ID Numbers:	4-2009-0420
Study First Received:	March 8, 2010
Last Updated:	January 31, 2012
Health Authority:	Korea: Food and Drug Administration Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:

Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013