Status:
COMPLETED
Comparison of Three Tranexamic Acid Dose Regimens in Patients Undergoing Cardiac Valve Surgery
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Cardiac Surgical Procedures
Blood Transfusion
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 debat...
Eligibility Criteria
Inclusion
- patients aged between 18 to 60 years old scheduled for cardiac valve surgery (replacement or plasty) requiring CPB
Exclusion
- known allergy to TXA, combined CABG operation or other cardiac procedures other than valve surgery, previous cardiac surgery, EF\<45% or cardiothoracic ratio\>0.65, serious coagulation disorder, serious hepatic insufficiency, receiving antiplatelet therapy at any time within 7 days of surgery, receiving low molecular weight heparin at any time within 24 hours of surgery, and pregnancy.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04911413
Start Date
September 1 2017
End Date
June 15 2021
Last Update
August 31 2021
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases
Beijing, Beijing Municipality, China, 100037