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

SHI Jia

Status and phase: Unknown; Phase 4

Conditions: Thromboses, Deep Vein; Tranexamic Acid Adverse Reaction

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03838328

Dose effect of TA on DVT

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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360 participants in 3 patient groups

Dose group 1

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Dose group 2

Experimental group

Description:

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.

Treatment:

Drug: Tranexamic Acid

Dose group 3

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid