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Trial record 86 of 422 for:    TRANEXAMIC ACID

Prospective Trial of 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: NCT01998438
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 28, 2013
Results First Submitted Date  ICMJE January 29, 2016
Results First Posted Date  ICMJE February 26, 2016
Last Update Posted Date February 26, 2016
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
Postoperative Blood Loss [ Time Frame: 24hrs postoperatively ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
Postoperative Blood Loss [ Time Frame: on the 7th day postoperatively ]
Change History Complete list of historical versions of study NCT01998438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2013)
Number of Participants Needs Allogenic Transfusion [ Time Frame: on the 7th day postoperatively ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 24, 2013)
Rate of Reexploration for Bleeding [ Time Frame: on the 7th day postoperatively ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prospective Trial of Tranexamic Acid in Cardiac Surgery
Official Title  ICMJE A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
Brief Summary Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE C.Surgical Procedure; Cardiac
Intervention  ICMJE Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902
Study Arms  ICMJE
  • Experimental: small dose
    10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
    Intervention: Drug: Tranexamic Acid
  • Experimental: medium dose
    20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
    Intervention: Drug: Tranexamic Acid
  • Experimental: large dose
    30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
    Intervention: Drug: Tranexamic Acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 16, 2014)
955
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2013)
810
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
  • Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
  • Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass

Exclusion Criteria:

  • Non-primary and emergency cardiac surgery
  • Disorder in coagulation function before surgery
  • Anemia before surgery
  • Definite liver and renal dysfunction
  • History of stroke
  • Pregnancy and lactation
  • Disabled in spirit or law
  • Fatal conditions such as cancer
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01998438
Other Study ID Numbers  ICMJE 2011GWH1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor  ICMJE Hongwen Ji
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hongwen Ji, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Haisong Lu Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date January 2016

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