ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01084044
Recruitment Status : Completed
First Posted : March 10, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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 Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. ulinastatin [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084044


Locations
Korea, Republic of
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01084044     History of Changes
Other Study ID Numbers: 4-2009-0420
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions
Urinastatin
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action