drugset / Trial / NCT02278263

Tranexamic Acid in Knee Joint Surgery

NCT02278263 ↗

Phase 4 Completed 150 enrolled University of Auckland, New Zealand
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Total knee joint replacement surgery can lead to significant blood loss, which can affect recovery after surgery. Tranexamic acid (TXA) is a medication which stops the breakdown of blood clots and therefore prevents blood loss. The optimal use of TXA remains a point of debate. Growing interest in the topical application of TXA (directly into the surgical wound) has been suggested as an alternative way of administering TXA, and may demonstrate similar effectiveness as when it is given intravenously. Therefore, this multicentred, randomized controlled trial, aims to investigate the safety and effectiveness of both topical and intravenous administrations of TXA in total knee joint surgery. The investigators predict that both routes of administration will demonstrate similar results when compared to placebo.

Timeline

Start
2014-12
Primary completion
2015-11
Completion
2016-03

Outcome

Met primary endpoint

paper Compared to the placebo group (1090 mL [923-1257]), blood loss was significantly lower in both treatment groups (P = .001 and P = .0003, respectively). PMID 28662956 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1.5 g Intravenous

Indications