drugset / Trial / NCT02540226

Effect of Topical and Intravenous Tranexamic Acid (TXA) on Thrombogenic Markers in Patients Undergoing Knee Replacement

NCT02540226

Phase 4 Completed 76 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Tranexamic acid (TXA) is a drug that is being used more frequently at the Hospital for Special Surgery to lessen the amount of blood loss after total knee replacement (TKR). It is an anti-fibrinolytic agent, which means that it promotes the formation of blood clots. TXA can be given either intravenously or topically (placed directly on the open wound) before wound closure. Patients with certain medical conditions have been found to have a high risk of thrombosis after being given intravenous TXA, which may lead to serious complications. However, to date, no high-risk patients have been identified for use of topical TXA. This study will look at thrombogenic markers (proteins found in blood that promote clot formation) after TXA is given either intravenously or topically. If the effect on these markers is similar between intravenous and topical use of TXA, then the safety of topical TXA should be questioned. Of note, these markers have never been measured after TXA has been given topically. As a result, this information would be important for the medical community.

Timeline

Start
2015-11-19
Primary completion
2018-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tranexamic Acid Small molecule 1 g Intravenous
Comparator Tranexamic Acid Small molecule 3 g Intravenous

Indications