NCT01191554

Dose-ranging Study of Tranexamic Acid in Valve Surgery

Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhage
• Valvular Heart Surgery

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	High and low dosage. Loading dose followed by continuous infusion in operation.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-08-31
• Last updated: 2012-11-06

Locations

1 site across 1 country: China