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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Lihuan, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier:
NCT01060163
First received: January 28, 2010
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Antifibrinolytics on Bleeding and Transfusion Outcomes in Patients Receiving Coronary Artery Bypass Surgery With Preoperative Clopidogrel Exposure

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Postoperative blood loss(chest drainage) [ Time Frame: on the 120th day postoperatively ] [ Designated as safety issue: No ]
  • Incidence of major bleeding [ Time Frame: on the 120th day postoperatively ] [ Designated as safety issue: No ]
  • RBC Transfusion (volume and rate) [ Time Frame: on the 120th day postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: on the 120th day postoperatively ] [ Designated as safety issue: Yes ]
  • Major morbidity [ Time Frame: on the 120th day postoperatively ] [ Designated as safety issue: Yes ]
    The major morbidity end points were defined as permanent disability caused by stroke, postoperative myocardial infarction, renal failure and respiratory failure.


Enrollment: 552
Study Start Date: January 2010
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060163

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

No publications provided by Cardiovascular Institute & Fuwai Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Li Lihuan, Professor and directior of the department of anaesthesiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M, Cardiovascular Institute & Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01060163     History of Changes
Other Study ID Numbers: the TRACED trial
Study First Received: January 28, 2010
Last Updated: November 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Cardiovascular Institute & Fuwai Hospital:
Clopidogrel
Tranexamic Acid
Cardiac Surgical Procedures
Hemostasis

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

ClinicalTrials.gov processed this record on August 18, 2014