Clinical trial NCT01060163: Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion
Official title: Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Clopidogrel
Tranexamic Acid
Cardiac Surgical Procedures
Hemostasis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-02-02
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Postoperative blood loss(chest drainage)
timeFrame: on the 120th day postoperatively
measure: Incidence of major bleeding
timeFrame: on the 120th day postoperatively
measure: RBC Transfusion (volume and rate)
timeFrame: on the 120th day postoperatively
Secondary outcomes:
measure: Mortality
timeFrame: on the 120th day postoperatively
measure: Major morbidity
timeFrame: on the 120th day postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University affiliated Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC
state: Beijing
city: Beijing
country: China
facility: General Hospital of Chinese People's Liberation Army
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Shanghai
country: China
facility: Shanghai Jiaotong University affiliated Chest Hospital
state: Shanghai
city: Xi'an
country: China
facility: the Fourth Military Medical University affiliated Xijing Hospital
state: Shanxi
city: Tianjin
country: China
facility: TEDA International Cardiovascular Hospital
state: Tianjin
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Lihuang Li, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Jia Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.