Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Tranexamic Acid; Drug: Saline

• Registration Number: NCT01060163
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2011-06
• Study Completion: 2011-10
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
group ET	Tranexamic Acid	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 EP	Saline	Patients receiving early CABG \<= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)
group LT	Tranexamic Acid	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 LP	Saline	Patients receiving late CABG \>7 days of the cessation of clopidogrel, treated with placebo(saline solution)
group BT	Tranexamic Acid	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 BP	Saline	Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution)

Primary Outcome Measures

Name	Time	Method
Postoperative blood loss(chest drainage)	on the 120th day postoperatively
Incidence of major bleeding	on the 120th day postoperatively
RBC Transfusion (volume and rate)	on the 120th day postoperatively

Secondary Outcome Measures

Name	Time	Method
Mortality	on the 120th day postoperatively
Major morbidity	on the 120th day postoperatively	The major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure.

Trial Locations

Locations (7)

Capital Medical University affiliated Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China

General Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China

Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC; 🇨🇳 Beijing, Beijing, China

Shanghai Jiaotong University affiliated Chest Hospital; 🇨🇳 Shanghai, Shanghai, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

TEDA International Cardiovascular Hospital; 🇨🇳 Tianjin, Tianjin, China

the Fourth Military Medical University affiliated Xijing Hospital; 🇨🇳 Xi'an, Shanxi, China