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Hemostatic and Anti-Inflammatory Effects of Ulinastatin and Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery

This study is currently recruiting participants.
Verified May 2012 by Cardiovascular Institute & Fuwai Hospital
Sponsor:
Information provided by (Responsible Party):
SHI Jia, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01060189
First received: January 28, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

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 and anti-inflammatory effect of ulinastatin and tranexamic acid in cardiac surgery.


Condition Intervention
Hemostasis
 Drug: UTI & TA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Hemostatic and Anti-Inflammatory Effects of Ulinastatin and Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Postoperative blood loss(chest drainage) [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: Yes ]
  • Perioperative allogeneic transfusions [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of reexploration for bleeding [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: Yes ]
  • Length of stay in ICU and hospital postoperatively [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: No ]
  • Coagulatory and fibrinolytic status [ Time Frame: 6hrs, 12hrs and 24hrs postoperatively ] [ Designated as safety issue: No ]
  • Inflammatory cytokines [ Time Frame: 6hrs, 12hrs and 24hrs postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: February 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulinastatin
1,000,000 units after anesthetic induction 1,000,000 units after heparinization 1,000,000 units after neutralization
 Drug: UTI & TA
Ulinastatin, tranexamic acid and the combination of the two
Experimental: Tranexamic Acid
15mg after heparinization 15mg after neutralization
 Drug: UTI & TA
Ulinastatin, tranexamic acid and the combination of the two
Experimental: Combination

Ulinastatin 1,000,000 units after anesthetic induction 1,000,000 units after heparinization 1,000,000 units after neutralization

Tranexamic Acid 15mg after heparinization 15mg after neutralization

 Drug: UTI & TA
Ulinastatin, tranexamic acid and the combination of the two
Placebo Comparator: Placebo
saline solution 50ml after anesthetic induction 50ml after heparinization 50ml after neutralization
 Drug: UTI & TA
Ulinastatin, tranexamic acid and the combination of the two

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 with CPB

Exclusion Criteria:

  • Non-primary cardiac surgery
  • Definite liver and renal dysfunction
  • Disorder in coagulation function
  • Allergy
  • Pregnancy and lactation
  • Disabled in spirit or law
  • Fatal conditions such as tumour
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060189

Contacts
Contact: Lihuan Li, MD 86-10-88398184 llhfw@sina.com
Contact: Jia Shi, MD 86-10-88398082 shiandypumc@sina.com

Locations
China, Beijing
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC Recruiting
Beijing, Beijing, China, 100037
Contact: Lihuan Li, MD     86-10-88398184     llhfw@sina.com    
Contact: Jia Shi, MD     86-10-88398082     shiandypumc@sina.com    
Principal Investigator: Lihuan Li, MD            
Sub-Investigator: Jia Shi, MD            
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Investigators
Study Chair: Lihuan Li, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Jia Shi, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
  More Information

No publications provided

Responsible Party: SHI Jia, Attending doctor of the department of anesthesiology and critical care, Fuwai Hospital, NCCD, PUMC & CAMS, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01060189     History of Changes
Other Study ID Numbers: UTI Trial China
Study First Received: January 28, 2010
Last Updated: May 3, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
ulinastatin
tranexamic acid
cardiac surgery procedures
hemostasis
anti-inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Hemostatics
Tranexamic Acid
Urinastatin
Therapeutic Uses
Pharmacologic Actions
Coagulants
Hematologic Agents
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013