drugset / Trial / NCT01191554

Dose-ranging Study of Tranexamic Acid in Valve Surgery

NCT01191554 ↗

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2011-09
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 mg/kg —
Subject Tranexamic Acid Small molecule 16 mg/kg —