Tranexamic Acid on Blood Loss and Transfusion in Cardiac Surgery

This study is currently recruiting participants. (see Contacts and Locations)
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

January 28, 2010
May 3, 2012
February 2010
December 2014   (final data collection date for primary outcome measure)
  • 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 ]
Blood loss (chest drainage) postoperatively Allogeneic transfusions perioperatively [ Time Frame: 8hrs, 16hrs, 24hrs and 48hrs postoperatively ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01060176 on ClinicalTrials.gov Archive Site
  • 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 ]
Length of stay in ICU and hospital postoperatively Rate of reexploration for hemostasis Coagulatory and fibrinolytic status Thromboelastography Inflammatory cytokines [ Time Frame: after the anesthetic induction, at the end of the operation, 6hrs and 24hrs postoperatively ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Tranexamic Acid on Blood Loss and Transfusion in Cardiac Surgery
A Multicenter Clinical Trial of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiopulmonary Bypass Cardiac Surgery

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Hemostasis
Drug: Tranexamic Acid
High, medium and low dosage, loading dose followed by continuous infusion in operation
  • Experimental: High dosage
    A loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h
    Intervention: Drug: Tranexamic Acid
  • Experimental: Medium dosage
    A loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h
    Intervention: Drug: Tranexamic Acid
  • Experimental: Low dosage
    A loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h
    Intervention: Drug: Tranexamic Acid
  • Placebo Comparator: Control
    Routine therapy without tranexamic acid
    Intervention: Drug: Tranexamic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
March 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Lihuan Li, MD 86-10-88398184 llhfw@sina.com
Contact: Jia Shi, MD 86-10-88398082 shiandypumc@sina.com
China
 
NCT01060176
TA Trial China
Yes
SHI Jia, Cardiovascular Institute & Fuwai Hospital
Cardiovascular Institute & Fuwai Hospital
Not Provided
Study Chair: Lihuan Li, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Jia Shi, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Cardiovascular Institute & Fuwai Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP