Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery

• Status: Unknown status
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SHI Jia
• Treatments: Tranexamic Acid

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