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Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01060163
Acronym
TRACED
Enrollment
552
Registered
2010-02-02
Start date
2010-01-31
Completion date
2011-10-31
Last updated
2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Clopidogrel, Tranexamic Acid, Cardiac Surgical Procedures, Hemostasis

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.

Interventions

DRUGTranexamic 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

DRUGSaline

Saline served as placebo

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Postoperative blood loss(chest drainage)on the 120th day postoperatively
Incidence of major bleedingon the 120th day postoperatively
RBC Transfusion (volume and rate)on the 120th day postoperatively

Secondary

MeasureTime frameDescription
Mortalityon the 120th day postoperatively
Major morbidityon the 120th day postoperativelyThe major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026