Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

NCT ID: NCT01060163

Last Updated: 2011-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-10-31

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Tranexamic Acid; Cardiac Surgical Procedures; Hemostasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group ET

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery

group EP

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline served as placebo

group LT

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery

group LP

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline served as placebo

group BT

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.

Group Type: EXPERIMENTAL

Tranexamic Acid

Intervention Type: DRUG

A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery

group BP

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

Saline served as placebo

Interventions

Tranexamic Acid

A bolus of 10 mg/kg after anesthetic induction over 10 min followed by a maintenance of 10 mg/kg/h for the duration of surgery

Intervention Type: DRUG

Saline

Saline served as placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Li Lihuan

Professor and directior of the department of anaesthesiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lihuang Li, MD

Role: STUDY_CHAIR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Jia Shi, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Locations

Capital Medical University affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC

Beijing, Beijing Municipality, China

General Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

Shanghai Jiaotong University affiliated Chest Hospital

Shanghai, Shanghai Municipality, China

the Fourth Military Medical University affiliated Xijing Hospital

Xi’an, Shanxi, China

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, Qi J, Li L. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013 Jun;148(6):538-47. doi: 10.1001/jamasurg.2013.1560.

Reference Type: DERIVED

PMID: 23426385 (View on PubMed)

Other Identifiers

the TRACED trial

Identifier Type: -

Identifier Source: org_study_id