Clinical trial NCT01064167: Tranexamic Acid in Off-pump Coronary Surgery
Official title: Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Off Pump Coronary Artery Bypass Surgery
Keywords: Tranexamic Acid
off-pump coronary Artery Bypass
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.

Detailed description: Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

Eligibility criteria: Inclusion Criteria:

* Patients for elective offpump coronary artery bypass surgery

Exclusion Criteria:

* A history of bleeding disorders
* Active chronic hepatitis or cirrhosis
* Chronic renal insufficiency (serum creatinine \> 2 mg/dL)
* Preoperative anemia (Hb \< 10 g/dL)
* Previous cardiac surgery
* Myocardial infarction \< 7 days before surgery

Primary outcomes:
measure: Number of Patients Required Allogenic Red Blood Cells Transfusion
timeFrame: 1month postoperative
Secondary outcomes:
measure: Postoperative Chest Tube Drainage
timeFrame: 24h postoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lihuan Li, M.D
role: STUDY_CHAIR
References:
citation: Wang G, Xie G, Jiang T, Wang Y, Wang W, Ji H, Liu M, Chen L, Li L. Tranexamic acid reduces blood loss after off-pump coronary surgery: a prospective, randomized, double-blind, placebo-controlled study. Anesth Analg. 2012 Aug;115(2):239-43. doi: 10.1213/ANE.0b013e3182264a11. Epub 2011 Jul 7.