Marinus D J Stowers1, James Aoina2, Andrew Vane2, Vaughan Poutawera2, Andrew G Hill3, Jacob T Munro4. 1. Department of Orthopaedics, Middlemore Hospital, Counties Manukau District Health Board (DHB), Auckland, New Zealand; Ko Awatea, Middlemore Hospital, Auckland, New Zealand. 2. Department of Orthopaedics, Tauranga Hospital, Bay of Plenty DHB, Tauranga, New Zealand. 3. South Auckland Clinical Campus, University of Auckland, Middlemore Hospital, Auckland, New Zealand; Department of Surgery, Middlemore Hospital, Counties Manukau DHB, Auckland, New Zealand. 4. Department of Surgery, School of Medicine, University of Auckland, Auckland Clinical School, Auckland, New Zealand; Department of Orthopaedics, Auckland City Hospital, Auckland DHB, Auckland, New Zealand.
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.
RCT Entities:
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.
Authors: Benjamin Jacob; Nadja Kloss; Sabrina Böhle; Julia Kirschberg; Timo Zippelius; Markus Heinecke; Georg Matziolis; Eric Röhner Journal: J Orthop Date: 2019-12-19