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Completed

NCT Number: NCT01060163

Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Capital Medical University affiliated Beijing Anzhen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

Saline

Drug

Saline served as placebo

Primary outcomes

  1. Postoperative blood loss(chest drainage)

    Time frame: on the 120th day postoperatively

  2. Incidence of major bleeding

    Time frame: on the 120th day postoperatively

  3. RBC Transfusion (volume and rate)

    Time frame: on the 120th day postoperatively

Secondary outcomes

  1. Mortality

    Time frame: on the 120th day postoperatively

  2. 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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Acronym: TRACED

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2010
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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