Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion (TRACED)

November 21, 2011 updated by: Li Lihuan, Chinese Academy of Medical Sciences, Fuwai Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Capital Medical University Affiliated Beijing Anzhen Hospital
      • Beijing, Beijing, China, 100037
        • Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC
      • Beijing, Beijing, China, 100853
        • General Hospital of Chinese People's Liberation Army
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Provincial Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Shanghai Jiaotong University Affiliated Chest Hospital
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • the Fourth Military Medical University affiliated Xijing Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300457
        • TEDA International Cardiovascular Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group ET
Patients receiving early CABG <=7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
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
Placebo Comparator: group EP
Patients receiving early CABG <= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)
Drug: Saline
Saline served as placebo
Experimental: group LT
Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
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
Placebo Comparator: group LP
Patients receiving late CABG >7 days of the cessation of clopidogrel, treated with placebo(saline solution)
Drug: Saline
Saline served as placebo
Experimental: group BT
Patients receiving CABG without preoperative clopidogrel exposure, treated with tranexamic acid with a bolus of 10 mg/kg after anesthetic induction and a maintenance of 10 mg/kg/h for the duration of surgery.
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
Placebo Comparator: group BP
Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution)
Drug: Saline
Saline served as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative blood loss(chest drainage)
Time Frame: on the 120th day postoperatively
on the 120th day postoperatively
Incidence of major bleeding
Time Frame: on the 120th day postoperatively
on the 120th day postoperatively
RBC Transfusion (volume and rate)
Time Frame: on the 120th day postoperatively
on the 120th day postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: on the 120th day postoperatively
on the 120th day postoperatively
Major morbidity
Time Frame: on the 120th day postoperatively
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Chair: Lihuang Li, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
  • Principal Investigator: Jia Shi, MD, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • the TRACED trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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