DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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:

Mortality

Major 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017