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Topical Application of Tranexamic Acid Reduces Postoperative Blood Loss in Total Knee ArthroplastyA Randomized, Controlled Trial
Jean Wong, MD, FRCPC1; Amir Abrishami, MD1; Hossam El Beheiry, MBBCh, PhD, FRCPC1; Nizar N. Mahomed, MD, ScD, FRCSC1; J. Roderick Davey, MD, FRCSC1; Rajiv Gandhi, MD, FRCSC1; Khalid A. Syed, MD, FRCSC1; Syed Muhammad Ovais Hasan, MD1; Yoshani De Silva, BSc1; Frances Chung, MD, FRCPC1
1 Departments of Anesthesia (J.W., A.A., H.E.B., S.M.O.H., Y.D.S., and F.C.) and Orthopedics (N.N.M., J.R.D., R.G., and K.A.S.), Toronto Western Hospital, University of Toronto, 2MC-434, 399 Bathurst Street, Toronto, ON M5T 2S8, Canada. E-mail address for J. Wong: jean.wong@uhn.on.ca
View Disclosures and Other Information
Disclosure: In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Physicians’ Services Incorporated Foundation. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

A commentary by David F. Dalury, MD, is available at www.jbjs.org/commentary and is linked to the online version of this article.
Investigation performed at Toronto Western Hospital, Toronto, Ontario, Canada

Copyright © 2010 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2010 Nov 03;92(15):2503-2513. doi: 10.2106/JBJS.I.01518
A commentary by David F. Dalury, MD, is available here
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Abstract

Background: 

Topical application of tranexamic acid to bleeding wound surfaces reduces blood loss in patients undergoing some major surgeries, without systemic complications. The objective of the present trial was to assess the efficacy and safety of the topical application of tranexamic acid on postoperative blood loss in patients undergoing primary unilateral total knee arthroplasty with cement.

Methods: 

In a prospective, double-blind, placebo-controlled trial, 124 patients were randomized to receive 1.5 or 3.0 g of tranexamic acid in 100 mL of normal saline solution or an equivalent volume of placebo (normal saline solution) applied into the joint for five minutes at the end of surgery. The primary outcome was blood loss calculated from the difference between the preoperative hemoglobin level and the corresponding lowest postoperative value or hemoglobin level prior to transfusion. The safety outcomes included Doppler ultrasound in all patients and measurement of plasma levels of tranexamic acid one hour after release of the tourniquet.

Results: 

Twenty-five patients were withdrawn for various reasons; therefore, ninety-nine patients were included in the intention-to-treat analysis. The postoperative blood loss was reduced in the 1.5 and 3-g tranexamic acid groups (1295 mL [95% confidence interval, 1167 to 1422 mL] and 1208 mL [95% confidence interval, 1078 to 1339 mL], respectively) in comparison with the placebo group (1610 mL [95% confidence interval, 1480 to 1738 mL]) (p < 0.017). The postoperative hemoglobin levels were higher in the 1.5 and 3.0-g tranexamic acid groups (10.0 g/dL [95% confidence interval, 9.5 to 10.4 g/dL] and 10.1 g/dL [95% confidence interval, 9.8 to 10.5 g/dL], respectively) in comparison with the placebo group (8.6 g/dL [95% confidence interval, 8.2 to 9 g/dL]) (p < 0.017). With the numbers studied, there was no difference in the rates of deep-vein thrombosis or pulmonary embolism between the three groups. Minimal systemic absorption of tranexamic acid was observed.

Conclusions: 

At the conclusion of a total knee arthroplasty with cement, topical application of tranexamic acid directly into the surgical wound reduced postoperative bleeding by 20% to 25%, or 300 to 400 mL, resulting in 16% to 17% higher postoperative hemoglobin levels compared with placebo, with no clinically important increase in complications being identified in the treatment groups.

Level of Evidence: 

Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    References

    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Jean Wong, MD, FRCPC
    Posted on February 11, 2011
    Dr. Wong responds to Dr. Alshryda
    Doctor , University of Toronto, Toronto Western Hospital, University Health Network, Toronto, Canada

    The authors thank Dr. Alshryda for his interest in our study. The assay to measure the plasma tranexamic acid levels was developed for our study by the Pediatric Laboratory at The Hospital for Sick Children in Toronto, Canada. In our study, we inferred that topical application of tranexamic acid to the artificial joint did not have adverse effects on the artificial joint material based on postoperative knee flexion, VAS pain scores, length of stay, and improvement in WOMAC scores postoperatively. We look forward to the publication of Dr. Alshryda's research.

    Sattar Alshryda
    Posted on January 14, 2011
    Article by Wong et al., "Topical Application of Tranexamic Acid Reduces Postoperative..."
    Orthopaedics, University Hospital of North Tees and Hartlepool, United Kingdom

    To the Editor:

    I join Mr. David Dalury complementing the authors of the article for their excellent work. Like them, we investigated the effect of topical Tranexamic acid in joint replacements in two randomized controlled trials, in total knee replacement (TRANX-K study, Eurdract number 2007-007813-35, 157 participants) and in total hip replacement (TRANX-H study- Eurdract number 2009-012141-34, 157 participants). The primary outcomes were blood transfusion rates. There was significant reduction in transfusion rates in both trials. We did not want to publish our results until we finished the last piece of research which is the BioTRANX study. It is a biomechanical study of the effect of Tranexamic acid on the biomechanical properties of the artificial joints material to see whether there is any determintal effects on these properties. It is almost finished. We aim to publish the full work by next year.

    Although, we tried measuring Tranexamic acid blood level, but we could not for financial and logistic reasons, so we are delighted to see this has been done and supported our views about topical use of Tranexamic acid in joint replacements.

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