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Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

NCT01596738 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-05-11

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Li Lihuan

    lead OTHER

Principal Investigators

  • Lihuan Li, M.D. · Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-03-31
Completion
2012-03-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596738 on ClinicalTrials.gov