Tranexamic Acid in Knee Surgery Study-A Multicentered, Randomized, Controlled Trial

Abstract

Background: Postoperative anemia following elective arthroplasty can lead to prolonged hospital stay and delays in rehabilitation and is often poorly tolerated in patients with cardiovascular disease. Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in total knee arthroplasty (TKA). However, questions over its optimal route of administration remain.

Methods: A double-blinded, placebo, multicentered, randomized, controlled trial investigating the efficacy of topical and systemic routes of a single intraoperative dose (1.5 g) of TXA was conducted. Patients undergoing primary, unilateral TKA were screened for eligibility. Eligible patients were consecutively enrolled from 5 New Zealand centers between July 2014 and November 2015. Three prospective groups running in parallel (topical TXA [tTXA], systemic TXA [sTXA], and placebo) were investigated for a primary outcome of estimated perioperative blood loss. An intention-to-treat analysis was used to compare outcomes between the study groups (P value <.05).

Results: One hundred and thirty-four patients across the 5 hospitals were recruited into the study. Estimated blood loss was equivalent in the 2 treatment groups, sTXA (749 mL [95% confidence interval, 637-860]) and tTXA (723 mL [620-826]). Compared to the placebo group (1090 mL [923-1257]), blood loss was significantly lower in both treatment groups (P = .001 and P = .0003, respectively). There were no significant differences in secondary outcomes, including rates of symptomatic deep vein thrombosis and pulmonary embolism (P = .759).

Conclusion: In the setting of elective TKA, a single 1.5-g dose of tTXA given intraoperatively either systemically or topically effectively reduces blood loss without an increase in complications.

Trial registration: ClinicalTrials.gov NCT02278263.

Keywords: TRACKS; blood transfusion; estimated blood loss; perioperative care; total knee arthroplasty; tranexamic acid.