Tranexamic Acid in Off-pump Coronary Surgery

Not Applicable

Completed

• Conditions: Off Pump Coronary Artery Bypass Surgery
• Interventions: Drug: Tranexamic Acid

• Registration Number: NCT01064167
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2009-10
• Study Completion: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Results First Submitted: 2010-08-30
• Results First Submitted QC: 2011-01-11
• Last Update Submitted: 2011-01-11
• Results First Posted: 2011-02-03
• Last Update Posted: 2011-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid group	Tranexamic Acid	-
Control group	Tranexamic Acid	-

Primary Outcome Measures

Name	Time	Method
Number of Patients Required Allogenic Red Blood Cells Transfusion	1month postoperative

Secondary Outcome Measures

Name	Time	Method
Postoperative Chest Tube Drainage	24h postoperative

Trial Locations

Locations (1)

Cardiovascular Institute and Fuwai Hospital; 🇨🇳 Beijing, China