Tranexamic Acid in Off-pump Coronary Surgery (TAOPCAB)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status: Completed

Conditions: Off Pump Coronary Artery Bypass Surgery

Treatments: Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01064167

FWMZ013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 2 patient groups, including a placebo group

Tranexamic Acid group

Experimental group

Treatment:

Drug: Tranexamic Acid

Control group

Placebo Comparator group

Treatment:

Drug: Tranexamic Acid