Status:
UNKNOWN
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
Lead Sponsor:
SHI Jia
Conditions:
Thromboses, Deep Vein
Tranexamic Acid Adverse Reaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac...
Eligibility Criteria
Inclusion
- Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written consent obtained
Exclusion
- Allergy or contraindication to tranexamic acid
- Severe renal impairment (serum creatinine \>250 μmol/l, or estimated creatinine clearance \<25 ml/min)
- Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- Thrombocytopenia defined as a platelet count \<100,000/ml
- Coagulopathy defined as an international normalized ratio \> 1.5 prior to surgery
- Currently enrolled in another perioperative interventional study
- Pregnancy or lactation
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2020
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03838328
Start Date
March 1 2019
End Date
March 31 2020
Last Update
February 12 2019
Active Locations (1)
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1
Chinese Academy of Medical Sciences， Fuwai Hospital
Beijing, China, 100037