Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion (TRACED)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Drug: Saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01060163

the TRACED trial

Details and patient eligibility

About

The use of platelet aggregation inhibitors, including aspirin and clopidogrel(CPDG), has become a standard management strategy for patients with acute coronary syndrome. On this background, an increasing percentage of patients presenting for surgical coronary revascularization is the subject to irreversible platelet inhibition.

Investigations on the effect of antiplatelet treatment on postoperative bleeding after cardiac surgery have shown that patients treated with antiplatelet agents until surgery have increased postoperative bleeding, and also an increased need for transfusions of blood products. As a result of the antiplatelet effect of clopidogrel, the frequency of serious bleeding complications has increased significantly, as seen in patients requiring coronary artery bypass grafting(CABG), especially when they received clopidogrel until surgery.

Tranexamic acid(TA) is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has seceded in 2007.The release of plasmin during cardiopulmonary bypass(CPB) activates fibrinolysis and may contribute to platelet dysfunction. Pharmacological inhibition of the fibrinolytic system may therefore ameliorate platelet dysfunction and fibrinolysis after CPB and decrease postoperative bleeding. Tranexamic acid prevents plasmin formation and inhibits fibrinolysis.

Concerning the cessation of aprotinin and the increasing proportion of patients with persistence on clopidogrel until their surgery, evolutional work is expected, especially in the eastern population.

The purpose of this study is to assess the effect of tranexamic acid in patients with clopidogrel and asprin ingestion until surgery. The investigators working hypothesis was that tranexamic acid would lower postoperative blood loss and transfusion requirements in these patients and would attenuate bleeding complication of antiplatelet therapy.

Enrollment: 552 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass

Exclusion criteria

• history of cardiac surgery
• hematocrit <33%
• platelet count <100,000/ml
• allergy to tranexamic acid
• recruited in other studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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552 participants in 6 patient groups, including a placebo group

group ET

Experimental group

Description:

Patients receiving early CABG \<=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.

Treatment:

Drug: Tranexamic Acid

group EP

Placebo Comparator group

Description:

Patients receiving early CABG \<= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)

Treatment:

Drug: Saline

group LT

Experimental group

Description:

Patients receiving late CABG \>7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.

Treatment:

Drug: Tranexamic Acid

group LP

Placebo Comparator group

Description:

Patients receiving late CABG \>7 days of the cessation of clopidogrel, treated with placebo(saline solution)

Treatment:

Drug: Saline

group BT

Experimental group

Description:

Patients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.

Treatment:

Drug: Tranexamic Acid

group BP

Placebo Comparator group

Description:

Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution)

Treatment:

Drug: Saline