Three Dose Regimen of Tranexamic Acid in Cardiac Surgery

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Unknown

Conditions: Hemostasis

Treatments: Drug: Tranexamic Acid; Drug: Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01060176

TXA Dosage Trial

Details and patient eligibility

About

Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
• Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
• Wrriten consent obtained

Exclusion criteria

• Non-primary cardiac surgery
• Preoperative liver or renal dysfunction
• Preoperative coagulation disorder
• Allergy
• Pregnancy or lactation
• Disabled in spirit or law
• Fatal conditions such as tumour

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 4 patient groups, including a placebo group

High dosage

Experimental group

Description:

Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h

Treatment:

Drug: Tranexamic Acid

Medium dosage

Experimental group

Description:

Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h

Treatment:

Drug: Tranexamic Acid

Low dosage

Experimental group

Description:

Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h

Treatment:

Drug: Tranexamic Acid

Control

Placebo Comparator group

Description:

Saline solution

Treatment:

Drug: Saline Solution