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NCT Number: NCT01596738

Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

The use of platelet aggregation inhibitors, including aspirin and clopidogrel, 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.

Tranexamic acid is a widely used antifibrinolytic agent, and is a promising substitute for aprotinin when the latter has been suspended in 2007.The release of plasmin during 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.

Many studies and meta-analyses have shown a reduction in postoperative bleeding and transfusion requirements of this antifibrinolytic drug in cardium revascularization surgery. Unfortunately the preoperative antiplatelet therapy was either neglected or obscure. Few studies specify the time between the last clopidogrel ingestion and surgery.Several studies were keen on the blood loss and allogeneic transfusion in patients who received their last clopidogrel or asprin within 7 days prior to coronary artery bypass grafting. Concerning the secession 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 less than 7 days prior to surgery. The working hypothesis is that tranexamic acid would reduce bleeding and transfusion requirements in this specific population of patients.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular Institute and Fuwai Hospital

Beijing, 100037, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women aged 18-85 years undergoing primary and isolated on-pump CABG
  • Last ingestion of clopidogrel and aspirin within 7 days preoperatively

Exclusion criteria

  • Previous cardiac surgery
  • Hematocrit <33%
  • Platelet count <100,000/ml
  • Allergy to tranexamic acid
  • Recruited in other studies

Treatment and study plan

Tranexamic Acid

Drug
  • Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
  • Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

Saline

Drug
  • Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
  • Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization

Primary outcomes

  1. Allogeneic erythrocyte, volume transfused

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge

  2. Allogeneic erythrocyte, percentage exposed

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge

Secondary outcomes

  1. Blood loss

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    The total volume of chest drainage from the end of the operation until the removal of the drainage tube

  2. Major bleeding

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    The incidence of major bleeding according to the CURE definition

  3. Reoperation

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days

    The incidence of reoperation for excessive bleeding

Sponsors and collaborators

Lead sponsor

Li Lihuan

Other

Registry information

Official study title

Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
May 11, 2012
Registry last updated
May 11, 2012

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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