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

Tranexamic Acid Adverse Reaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03838328
• Other study ID #: Dose effect of TA on DVT
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2019
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Jia Shi, M.D.
• Phone: 86 10 88322467
• Email: shiandypumc[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: March 31, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboses, Deep Vein
• Thrombosis
• Tranexamic Acid Adverse Reaction
• Venous Thrombosis

Intervention

Drug:
• Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
SHI Jia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of deep venous thrombosis	Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound	Within 7 days postoperatively
Secondary	The rate of new-onset thrombotic events	Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism	Within 90 days postoperatively
Secondary	The rate of allogeneic RBC transfusion	Allogeneic blood product includes packed red blood cell	Within 30 days postoperatively
Secondary	The volume of allogeneic RBC transfusion	Allogeneic blood product includes packed red blood cell	Within 30 days postoperatively
Secondary	Length of stay in ICU and hospital	The time interval between the end of the operation and the discharge from ICU or the hospital.	Within 90 days postoperatively