Comparison of Floseal® and Tranexamic Acid on Bleeding Control After Total Knee Arthroplasty
Status:
Unknown status
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
The total knee arthroplasty (TKA) is a well established option for the treatment of
osteoarthritis in this joint. Nevertheless, there are still some concerns related to the
peri-operative management of elderly patients, highlighting the complications related to
medical comorbidity and bleeding produced by surgery. One of the proposed methods to decrease
postoperative bleeding, which has been accumulating favorable evidence, is the use of
tranexamic acid (TA). Several studies (including prospective randomized trials with placebo
group) showed excellent results with TA intravenous administration during TKA, reducing the
amount of bleeding, the drop in hemoglobin and the need for blood transfusion. Another
alternative to minimize bleeding is the use of topical hemostatic agent Floseal®, composed of
thrombin and bovine gelatin. This substance has presented significant benefits on bleeding
control in several areas of medicine, including orthopedic surgery, but no action has yet
been established in TKA. The main objective is to evaluate the amount of bleeding, the drop
in hemoglobin and the need for blood transfusion after TKA, comparing the use of TA, Floseal®
and a control group. The secondary objective is to evaluate the rate of adverse events in the
studied groups.