Clinical Trials Directory

Trials / Completed

CompletedNCT01064167

Tranexamic Acid in Off-pump Coronary Surgery

Tranexamic Acid Reduces Blood Loss After Off-pump Coronary Artery Bypass Grafting

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
231 (actual)
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTranexamic AcidIn tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.

Timeline

Start date
2009-02-01
Primary completion
2009-10-01
Completion
2009-12-01
First posted
2010-02-08
Last updated
2011-02-03
Results posted
2011-02-03

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01064167. Inclusion in this directory is not an endorsement.