Dose-ranging Study of Tranexamic Acid in Valve Surgery

Not Applicable

Completed

• Conditions: Hemorrhage; Valvular Heart Surgery
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT01191554
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-08-31
• Study Start: 2010-09
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dosage	Tranexamic Acid	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.
Low dosage	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
Frequency of allogeneic red blood cells transfused	7 days post-operation

Secondary Outcome Measures

Name	Time	Method
Chest tube drainage	24 hours post-operation

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital; 🇨🇳 Beijing, China