Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01060189
Previous Study | Return to List | Next Study

Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac 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: NCT01060189
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.

Condition or disease Intervention/treatment Phase
Hemostasis Drug: Ulinastatin Drug: Tranexamic Acid Drug: Saline Solution Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
Actual Study Start Date : April 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Ulinastatin
1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization
Drug: Ulinastatin
Experimental: Tranexamic Acid
15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization
Drug: Tranexamic Acid
Placebo Comparator: Placebo
50ml saline solution before skin incision; 50ml saline solution after neutralization
Drug: Saline Solution



Primary Outcome Measures :
  1. Postoperative blood loss [ Time Frame: Postoperatively ]
    Defined as the total volume of chest drainage postoperatively


Secondary Outcome Measures :
  1. Rate of reexploration for bleeding [ Time Frame: Postoperatively ]
  2. Rate of major bleeding [ Time Frame: Perioperatively ]
    Major bleeding is defined according to the CURE study

  3. Transfusion of allogeneic erythrocytes [ Time Frame: Perioperatively ]
    Rate of exposure and volume of allogeneic erythrocytes transfused

  4. Transfusion of fresh frozen plasma (FFP) [ Time Frame: Perioperatively ]
    Rate of exposure and volume of FFP transfused

  5. Transfusion of allogeneic platelets [ Time Frame: Perioperatively ]
    Rate of exposure and volume of allogeneic platelets transfused

  6. Length of stay in ICU and hospital postoperatively [ Time Frame: Postoperatively ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
  • Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
  • Coronary artery disease patients requiring coronary revascularization surgery with CPB

Exclusion Criteria:

  • Non-primary cardiac surgery
  • Definite liver or renal dysfunction
  • Disorder in coagulation function
  • Allergy
  • Pregnancy or lactation
  • Disabled in spirit or law
  • Fatal conditions such as tumour

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): NCT01060189


Locations
Layout table for location information
China, Beijing
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
Layout table for investigator information
Study Chair: Lihuan Li, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Jia Shi, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SHI Jia, Associated Professor and Vice Chair of department of anesthesiology, Fuwai Hospital, NCCD, PUMC & CAMS, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01060189    
Other Study ID Numbers: UTI Pilot Study
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Keywords provided by SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital:
ulinastatin
tranexamic acid
cardiac surgery procedures
hemostasis
Additional relevant MeSH terms:
Layout table for MeSH terms
Tranexamic Acid
Urinastatin
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors