Blood-saving Effect of Combined Intravenous Tranexamic Acid With Topical Floseal® Application Total Hip Arthroplasty
Status:
Recruiting
Trial end date:
2020-07-31
Target enrollment:
Participant gender:
Summary
Total hip arthroplasty (THA) is an excellent surgical procedure for patients with end-stage
hip diseases. However, THA is associated with considerable blood loss and increasing needs
for allogenic blood transfusion. Tranexamic acid (TXA) was reportedly effective reducing
total blood loss (TBL) after standard THA. However, a TBL of one L is still high for elderly
patients.
Floseal (Baxter, Deerfield, Illinois), a thrombin-based hemostatic agent, have been widely
used in surgical procedure. However, there is no study investigating the effect of Floseal in
THA procedures.This study anticipated that combination with the two different mechanism of
topical hemostatic agent, Floseal, and intravenous TXA can bring a synergistic blood saving
effect in THA patients.
Purpose:
Our purpose of this study therefore is to conduct a prospective randomized controlled trial
to investigate the blood-conservation effect of combination of intravenous TXA and topical
Floseal in a primary THA procedure.
Material and Methods:
The patients who are enrolled in this study will be assigned into three groups. The first
group will be treated by combination of 1 g of TXA pre-operatively and two boluses TXA
post-operatively intravenously and Floseal topical application, the second group by 1 g of
TXA pre-operatively and two boluses TXA postoperatively intravenously without Floseal use,
and the third group was control group which will be treated without TXA and Floseal. This
study will observe whether there is difference in the blood-conservation effect by total
blood loss calculation, hemoglobin loss and transfusion requirement between these three
groups.
This study anticipate that combined use of intravenous TXA and Floseal in THA procedure is
more effective in decreasing blood loss and blood transfusion than intravenous TXA
application alone, and this formula do not increase the risk of thromboembolic disease.