Clinical trial NCT01596738: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass Graft
Keywords: Coronary Artery Disease
Coronary Artery Bypass Graft
Platelet Aggregation Inhibitors
Tranexamic Acid
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2012-05-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Allogeneic erythrocyte, volume transfused
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Allogeneic erythrocyte, percentage exposed
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Secondary outcomes:
measure: Blood loss
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Major bleeding
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
measure: Reoperation
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, NCCD, PUMC & CAMS
name: Lihuan Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: