Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
Overview
- Phase
- Phase 4
- Intervention
- Tranexamic Acid
- Conditions
- Thromboses, Deep Vein
- Sponsor
- SHI Jia
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- The incidence of deep venous thrombosis
- Last Updated
- 7 years ago
Overview
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 surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
Investigators
SHI Jia
Associate Professor and Vice Chair of the Anesthesiology Department
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- •Written consent obtained
Exclusion Criteria
- •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
Arms & Interventions
Dose group 1
The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
Intervention: Tranexamic Acid
Dose group 2
The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
Intervention: Tranexamic Acid
Dose group 3
The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
Intervention: Tranexamic Acid
Outcomes
Primary Outcomes
The incidence of deep venous thrombosis
Time Frame: Within 7 days postoperatively
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Secondary Outcomes
- The rate of allogeneic RBC transfusion(Within 30 days postoperatively)
- Length of stay in ICU and hospital(Within 90 days postoperatively)
- The volume of allogeneic RBC transfusion(Within 30 days postoperatively)
- The rate of new-onset thrombotic events(Within 90 days postoperatively)