Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

NCT01596738 | Completed DMC

• 1 other identifier: Fuwai2008
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Artery Bypass Graft

Keywords

Coronary Artery Disease; Coronary Artery Bypass Graft; Platelet Aggregation Inhibitors; Tranexamic Acid

Outcome Measures

Primary Outcomes (2)

• Allogeneic erythrocyte, volume transfused

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

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

• Allogeneic erythrocyte, percentage exposed

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

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

Secondary Outcomes (3)

• Blood loss

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

• Major bleeding

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

• Reoperation

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

Study Arms (2)

Tranexamic Acid group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Tranexamic Acid DRUG

1. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction 2. Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization

Tranexamic Acid group

Saline DRUG

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

Placebo group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Li Lihuan: lead

Study Sites (1)

Cardiovascular Institute and Fuwai Hospital

Beijing, 100037, China

Location

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

• Lihuan Li, M.D.

  Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and director of the department of anesthesiology and critical care, NCCD, PUMC & CAMS

Study Record Dates

• First Submitted: May 5, 2012
• First Posted: May 11, 2012
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

CN (1)