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

Phase 4

• Conditions: Thromboses, Deep Vein; Tranexamic Acid Adverse Reaction
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT03838328
• Lead Sponsor: SHI Jia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-09
• Last Update Submitted: 2019-02-09
• Study First Posted: 2019-02-12
• Last Update Posted: 2019-02-12
• Study Start: 2019-03-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose group 3	Tranexamic Acid	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.
Dose group 1	Tranexamic Acid	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.
Dose group 2	Tranexamic Acid	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.

Primary Outcome Measures

Name	Time	Method
The incidence of deep venous thrombosis	Within 7 days postoperatively	Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound

Secondary Outcome Measures

Name	Time	Method
Length of stay in ICU and hospital	Within 90 days postoperatively	The time interval between the end of the operation and the discharge from ICU or the hospital.
The volume of allogeneic RBC transfusion	Within 30 days postoperatively	Allogeneic blood product includes packed red blood cell
The rate of allogeneic RBC transfusion	Within 30 days postoperatively	Allogeneic blood product includes packed red blood cell
The rate of new-onset thrombotic events	Within 90 days postoperatively	Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences， Fuwai Hospital; 🇨🇳 Beijing, China