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Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

Primary Purpose

Coronary Artery Disease, Coronary Artery Bypass Graft

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tranexamic Acid
Saline
Sponsored by
Li Lihuan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Coronary Artery Bypass Graft, Platelet Aggregation Inhibitors, Tranexamic Acid

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Cardiovascular Institute and Fuwai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid group

Placebo group

Arm Description

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

Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization

Outcomes

Primary Outcome Measures

Allogeneic erythrocyte, volume transfused
Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge
Allogeneic erythrocyte, percentage exposed
The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge

Secondary Outcome Measures

Blood loss
The total volume of chest drainage from the end of the operation until the removal of the drainage tube
Major bleeding
The incidence of major bleeding according to the CURE definition
Reoperation
The incidence of reoperation for excessive bleeding

Full Information

First Posted
May 5, 2012
Last Updated
May 9, 2012
Sponsor
Li Lihuan
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1. Study Identification

Unique Protocol Identification Number
NCT01596738
Brief Title
Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation
Official Title
Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Lihuan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Bypass Graft
Keywords
Coronary Artery Disease, Coronary Artery Bypass Graft, Platelet Aggregation Inhibitors, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid group
Arm Type
Experimental
Arm Description
Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization
Primary Outcome Measure Information:
Title
Allogeneic erythrocyte, volume transfused
Description
Total volume of allogeneic erythrocyte transfused, from the beginning of the operation until discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Allogeneic erythrocyte, percentage exposed
Description
The percentage of patients exposed to allogeneic erythrocyte, from the beginning of the operation until discharge
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary Outcome Measure Information:
Title
Blood loss
Description
The total volume of chest drainage from the end of the operation until the removal of the drainage tube
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Major bleeding
Description
The incidence of major bleeding according to the CURE definition
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days
Title
Reoperation
Description
The incidence of reoperation for excessive bleeding
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women aged 18-85 years undergoing primary and isolated on-pump CABG Last ingestion of clopidogrel and aspirin within 7 days preoperatively Exclusion Criteria: Previous cardiac surgery Hematocrit <33% Platelet count <100,000/ml Allergy to tranexamic acid Recruited in other studies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihuan Li, M.D.
Organizational Affiliation
Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China

12. IPD Sharing Statement

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Tranexamic Acid in On-pump CABG With Premature Clopidogrel Cessation

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