Cardiovascular Institute and Fuwai Hospital
Beijing, 100037, China
NCT Number: NCT01596738
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Beijing, 100037, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
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
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
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
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
The incidence of reoperation for excessive bleeding
Li Lihuan
Other
Tranexamic Acid in Patients Receiving Primary and Isolated On-pump CABG With Premature Clopidogrel Cessation to Reduce Postoperative Bleeding and Transfusion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00622791
Arterial Occlusive Diseases, Arteriosclerosis
São Paulo, Brazil
View Trial DetailsNCT07468955
Arterial Occlusive Diseases, Arteriosclerosis
Kütahya, Center, Turkey (Türkiye)
View Trial DetailsNCT06029517
Arterial Occlusive Diseases, Arteriosclerosis
Buffalo, New York, United States
View Trial DetailsNCT04058990
Arterial Occlusive Diseases, Arteriosclerosis
Kitakyushu, Fukuoka, Japan
View Trial Details