NCT04911413

Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study compares the effect of three different dose levels of tranexamic acid（TXA）in reducing blood loss and transfusion requirements in cardiac valve surgery.

Detailed description

The effect of TXA to reduce perioperative blood loss and blood transfusion has been well established in many trials, but the optimal dosage of TXA in cardiac surgery has always been a problem of debate. This is a single-center randomized controlled trial to study different dose regimens of TXA in cardiac surgery. We use three different dose levels of TXA in cardiac valve surgery with CPB, and see if there are any differences in perioperative blood loss and transfusion requirements. Serious adverse events and seizure attacks are also recorded until three months after surgery.

Conditions

• Cardiac Surgical Procedures
• Blood Transfusion
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	Tranexamic acid	The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-03-05
• Completion: 2021-06-15
• First posted: 2021-06-03
• Last updated: 2021-08-31

Locations

1 site across 1 country: China