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Tranexamic Acid on Blood Loss and Transfusion in 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:
NCT01060176
First received: January 28, 2010
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
  Purpose

Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Different dosage of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded. The study hypothesis is that tranexamic acid could reduce blood loss and allogeneic transfusion in cardiopulmonary bypass cardiac surgery. Furthermore, tranexamic acid could decrease inflammatory reaction in cardiac surgery.


Condition Intervention
Hemostasis
 Drug: Tranexamic Acid

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: A Multicenter Clinical Trial of Tranexamic Acid on Blood Loss and Allogeneic Transfusions 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:
  • Blood loss (chest drainage) postoperatively [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: Yes ]
  • Allogeneic transfusions [ Time Frame: on the 30th day postoperatively ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 1200
Study Start Date: February 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High dosage
A loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h
 Drug: Tranexamic Acid
High, medium and low dosage, loading dose followed by continuous infusion in operation
Experimental: Medium dosage
A loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h
 Drug: Tranexamic Acid
High, medium and low dosage, loading dose followed by continuous infusion in operation
Experimental: Low dosage
A loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h
 Drug: Tranexamic Acid
High, medium and low dosage, loading dose followed by continuous infusion in operation
Placebo Comparator: Control
Routine therapy without tranexamic acid
 Drug: Tranexamic Acid
High, medium and low dosage, loading dose followed by continuous infusion in operation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
  • Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass

Exclusion Criteria:

  • Non-primary cardiac surgery
  • Definite liver and renal dysfunction
  • Disorder in coagulation function
  • Drugs or interventions influencing inflammatory status such as ulinastatin
  • 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: NCT01060176

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: NCT01060176     History of Changes
Other Study ID Numbers: TA 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:
tranexamic acid
cardiac surgery procedures
hemostasis
anti-inflammation

Additional relevant MeSH terms:
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013