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Dose-ranging Study of Tranexamic Acid in Valve Surgery

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ClinicalTrials.gov Identifier: NCT01191554
Recruitment Status : Completed
First Posted : August 31, 2010
Last Update Posted : November 6, 2012
Sponsor:
Information provided by (Responsible Party):
Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

August 30, 2010
August 31, 2010
November 6, 2012
September 2010
September 2011   (Final data collection date for primary outcome measure)
Frequency of allogeneic red blood cells transfused [ Time Frame: 7 days post-operation ]
Same as current
Complete list of historical versions of study NCT01191554 on ClinicalTrials.gov Archive Site
  • Chest tube drainage [ Time Frame: 6 hours post-operation ]
  • Chest tube drainage [ Time Frame: 24 hours post-operation ]
Same as current
Not Provided
Not Provided
 
Dose-ranging Study of Tranexamic Acid in Valve Surgery
Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Hemorrhage
  • Valvular Heart Surgery
Drug: Tranexamic Acid
High 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 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
    Intervention: Drug: Tranexamic Acid
  • Experimental: Low dosage
    A loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
    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.
 
Completed
175
170
October 2011
September 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

  • a history of bleeding disorders
  • active chronic hepatitis or cirrhosis
  • chronic renal insufficiency (serum creatinine > 2 mg/dl)
  • preoperative anemia (Hb < 10 g/dl)
  • previous cardiac surgery
  • urgent and emergency surgery
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01191554
FW2009006
Yes
Not Provided
Not Provided
Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Not Provided
Study Chair: Lihuan Li, M.D Fuwai Hospital & Cardiovascular Institute
Chinese Academy of Medical Sciences, Fuwai Hospital
November 2012

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