Tranexamic Acid in Clopidogrel Exposure to Decrease Hemorrhage and Transfusion

NCT01060163 | Completed DMC

• 1 other identifier: the TRACED trial
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Clopidogrel; Tranexamic Acid; Cardiac Surgical Procedures; Hemostasis

Outcome Measures

Primary Outcomes (3)

• Postoperative blood loss(chest drainage)

  on the 120th day postoperatively

• Incidence of major bleeding

  on the 120th day postoperatively

• RBC Transfusion (volume and rate)

  on the 120th day postoperatively

Secondary Outcomes (2)

• Mortality

  on the 120th day postoperatively

• Major morbidity

  on the 120th day postoperatively

Study Arms (6)

group ET

EXPERIMENTAL

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

group EP

PLACEBO COMPARATOR

Patients receiving early CABG \<= 7 days of the cessation of clopidogrel, treated with placebo(saline solution)

Drug: Saline

group LT

EXPERIMENTAL

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

group LP

PLACEBO COMPARATOR

Patients receiving late CABG \>7 days of the cessation of clopidogrel, treated with placebo(saline solution)

Drug: Saline

group BT

EXPERIMENTAL

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

group BP

PLACEBO COMPARATOR

Patients receiving CABG without preoperative clopidogrel exposure, treated with placebo(saline solution)

Drug: Saline

Interventions

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

group BT; group ET; group LT

Saline DRUG

Saline served as placebo

group BP; group EP; group LP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring primary and isolated coronary artery bypass grafting with cardiopulmonary bypass

You may not qualify if:

• history of cardiac surgery
• hematocrit \<33%
• platelet count \<100,000/ml
• allergy to tranexamic acid
• recruited in other studies

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (7)

Capital Medical University affiliated Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Cardiovascular Institute and Fuwai Hospital, CMAS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

General Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100853, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Shanghai Jiaotong University affiliated Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

the Fourth Military Medical University affiliated Xijing Hospital

Xi’an, Shanxi, 710032, China

Location

TEDA International Cardiovascular Hospital

Tianjin, Tianjin Municipality, 300457, China

Location

Related Publications (1)

• Shi J, Ji H, Ren F, Wang G, Xu M, Xue Y, Chen M, Qi J, Li L. Protective effects of tranexamic acid on clopidogrel before coronary artery bypass grafting: a multicenter randomized trial. JAMA Surg. 2013 Jun;148(6):538-47. doi: 10.1001/jamasurg.2013.1560.

  PMID: 23426385 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Tranexamic Acid; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lihuang Li, MD

  Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

  STUDY CHAIR

• Jia Shi, MD

  Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and directior of the department of anaesthesiology, Cardiovascular Institute and Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union M

Study Record Dates

• First Submitted: January 28, 2010
• First Posted: February 2, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 22, 2011

Record last verified: 2011-11

Locations

CN (7)