Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion (TRACED)
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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 |
- 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 ]
- 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 |
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| 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 | |
| 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
| 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 May 19, 2013