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Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Lihuan, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M
ClinicalTrials.gov Identifier:
NCT01596738
First received: May 5, 2012
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Coronary Artery Bypass Graft
 Drug: Tranexamic Acid
Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cardiovascular Institute & Fuwai Hospital:

Primary Outcome Measures:
  • Allogeneic erythrocyte, volume transfused [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge

  • Allogeneic erythrocyte, percentage exposed [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge


Secondary Outcome Measures:
  • Blood loss [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    The total volume of chest drainage from the end of the operation until the removal of the drainage tube

  • Major bleeding [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    The incidence of major bleeding according to the CURE definition

  • Reoperation [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days ] [ Designated as safety issue: No ]
    The incidence of reoperation for excessive bleeding


Enrollment: 120
Study Start Date: October 2008
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid group
  1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
  2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
 Drug: Tranexamic Acid
  1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
  2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
Placebo Comparator: Placebo group
  1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
  2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
 Drug: Saline
  1. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
  2. Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596738

Locations
China
Cardiovascular Institute and Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Li Lihuan
Investigators
Principal Investigator: Lihuan Li, M.D. Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS
  More Information

No publications provided

Responsible Party: Li Lihuan, Professor and director of the department of anesthesiology and critical care, NCCD, PUMC & CAMS, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M
ClinicalTrials.gov Identifier: NCT01596738     History of Changes
Other Study ID Numbers: Fuwai2008
Study First Received: May 5, 2012
Last Updated: May 9, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
Coronary Artery Disease
Coronary Artery Bypass Graft
Platelet Aggregation Inhibitors
Tranexamic Acid

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Anesthetics
Clopidogrel
Platelet Aggregation Inhibitors
Tranexamic Acid
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hematologic Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 16, 2013