Topical Tranexamic Acid in Primary Total Hip Replacement
Research type
Research Study
Full title
Randomised Controlled Trial of the Use of Topical Application of Tranexamic Acid in Primary Total Hip Replacement (TRANX-H).
Sponsor organisation
North Tees and Hartlepool NHS FT
Eudract number
2009-012141-34
ISRCTN Number
N/A
Research summary
Today??s aging population has resulted in an increase in the number of people who need joint. The fifth annual report of the National Joint Registry showed that there were 66 839 total hip replacements (THRs) performed in England and Wales in 2007. Literature showed that 30-72% of patients who had THR needed 1-3 units of blood. Although safer than ever, blood transfusion is not free of risk and cost.Tranexamic acid (TA) has been successfully used to stop bleeding in various medical and surgical fields. Our hypothesis, that local TA may provide a high concentration at the bleeding site but little or no systemic side effects. To be able to assess the effect of Tranexamic acid on blood loss after total hip replacement, we need to make comparisons between those who are given the drug or those who are not. In this study, one group will receive Tranexamic acid and a second group will receive Placebo (a dummy solution which looks like Tranexamic acid but contains no active ingredient). The study medicine which can be either Tranexamic acid or a placebo will be applied topically to the exposed tissue around the hip joint prior to the wound closure and tourniquet release. It is anticipated that this method of administration will be quicker, easier and have less systemic side effect.Apart from blood loss and blood transfusion rate, we will also measure other health issues that might be affected by the Tranexamic acid such length of stay, cost and complications and compare them between the two groups.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
09/H0906/62
Date of REC Opinion
29 Jun 2009
REC opinion
Further Information Favourable Opinion