Dose-ranging Study of Tranexamic Acid in Valve Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guyan Wang, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01191554
First received: August 30, 2010
Last updated: November 2, 2012
Last verified: November 2012
  Purpose

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 Intervention
Hemorrhage
Valvular Heart Surgery
Drug: Tranexamic Acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Frequency of allogeneic red blood cells transfused [ Time Frame: 7 days post-operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Chest tube drainage [ Time Frame: 6 hours post-operation ] [ Designated as safety issue: No ]
  • Chest tube drainage [ Time Frame: 24 hours post-operation ] [ Designated as safety issue: No ]

Enrollment: 175
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01191554

Locations
China
Cardiovascular Institute and Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Cardiovascular Institute & Fuwai Hospital
Investigators
Study Chair: Lihuan Li, M.D Fuwai Hospital & Cardiovascular Institute
  More Information

No publications provided

Responsible Party: Guyan Wang, Associate Professor, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01191554     History of Changes
Other Study ID Numbers: FW2009006
Study First Received: August 30, 2010
Last Updated: November 2, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
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 July 23, 2014