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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hemorrhage Valvular Heart Surgery Drug: Tranexamic Acid Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Tranexamic Acid
High 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 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume.
Drug: Tranexamic Acid
High and low dosage. Loading dose followed by continuous infusion in operation.



Primary Outcome Measures :
  1. Frequency of allogeneic red blood cells transfused [ Time Frame: 7 days post-operation ]

Secondary Outcome Measures :
  1. Chest tube drainage [ Time Frame: 6 hours post-operation ]
  2. Chest tube drainage [ Time Frame: 24 hours post-operation ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191554


Locations
China
Cardiovascular Institute and Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
Study Chair: Lihuan Li, M.D Fuwai Hospital & Cardiovascular Institute

Responsible Party: Guyan Wang, Associate Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01191554     History of Changes
Other Study ID Numbers: FW2009006
First Posted: August 31, 2010    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants