Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion
Information source: Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Tranexamic Acid (Drug); Saline (Drug)
Phase: N/A
Status: Completed
Sponsored by: Cardiovascular Institute & Fuwai Hospital Official(s) and/or principal investigator(s): Lihuang Li, MD, Study Chair, Affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC Jia Shi, MD, Principal Investigator, Affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
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.
Clinical Details
Official title: Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Postoperative blood loss(chest drainage)Incidence of major bleeding RBC Transfusion (volume and rate)
Secondary outcome: MortalityMajor morbidity
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Capital Medical University affiliated Beijing Anzhen Hospital, Beijing, Beijing 100029, China
Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC, Beijing, Beijing 100037, China
General Hospital of Chinese People's Liberation Army, Beijing, Beijing 100853, China
Fujian Provincial Hospital, Fuzhou, Fujian 350001, China
Shanghai Jiaotong University affiliated Chest Hospital, Shanghai, Shanghai 200030, China
the Fourth Military Medical University affiliated Xijing Hospital, Xi'an, Shanxi 710032, China
TEDA International Cardiovascular Hospital, Tianjin, Tianjin 300457, China
Additional Information
Starting date: January 2010
Last updated: November 21, 2011
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