Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Tranexamic Acid
- Conditions
- Hemorrhage
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Enrollment
- 175
- Locations
- 1
- Primary Endpoint
- Frequency of allogeneic red blood cells transfused
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Guyan Wang
Associate Professor
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility 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
Arms & Interventions
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: Tranexamic Acid
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: Tranexamic Acid
Outcomes
Primary Outcomes
Frequency of allogeneic red blood cells transfused
Time Frame: 7 days post-operation
Secondary Outcomes
- Chest tube drainage(24 hours post-operation)