Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

Coronary Artery Disease Clinical Trial

— TRACED  

Official title:

Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060163
• Other study ID #: the TRACED trial
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: November 21, 2011
• Start date: January 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• 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
• Saline
Saline served as placebo

Locations

Country	Name	City	State
China	Capital Medical University affiliated Beijing Anzhen Hospital	Beijing	Beijing
China	Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC	Beijing	Beijing
China	General Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	Shanghai Jiaotong University affiliated Chest Hospital	Shanghai	Shanghai
China	TEDA International Cardiovascular Hospital	Tianjin	Tianjin
China	the Fourth Military Medical University affiliated Xijing Hospital	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative blood loss(chest drainage)		on the 120th day postoperatively	No
Primary	Incidence of major bleeding		on the 120th day postoperatively	No
Primary	RBC Transfusion (volume and rate)		on the 120th day postoperatively	No
Secondary	Mortality		on the 120th day postoperatively	Yes
Secondary	Major morbidity	The major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure.	on the 120th day postoperatively	Yes