Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial

Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial

The Journal of Arthroplasty xxx (2016) 1e2 Contents lists available at ScienceDirect The Journal of Arthroplasty journal homepage: www.arthroplastyj...

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The Journal of Arthroplasty xxx (2016) 1e2

Contents lists available at ScienceDirect

The Journal of Arthroplasty journal homepage: www.arthroplastyjournal.org

Letter to the Editor Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial

In Reply: As the corresponding author, I would like to thank you for your interest and keen attention to the details of our article “Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial.” Calculating Blood Loss The initial patient blood volume was given from the formula described by Nadler et al [1]. The information, namely preoperative blood volume, garnered from this was subsequently used in accordance with the method described by Jacobsson et al [2], which has been emulated in several peer-reviewed articles, including that of Good et al, which directly relates to our subject matter [3]. From this, both hemoglobin (Hb) and total blood loss were calculated. Two of our primary end points were lowest postoperative Hb and transfusion. Thus, blood/Hb loss in patients requiring transfusion was calculated based on their lowest postoperative value. In addition, the comment regarding Hb drop being greatest between postoperative days 4 and 5 was not in concordance with our data. Daily Hb/hematocrit values demonstrated a plateau before discharge between days 2 and 4 in all patients monitored for the study. The calculation of evident blood loss in the operating room is notoriously inaccurate. We decided inclusion of this variable may cloud the true goals of the study. In addition, evident blood loss in the operating room is mainly an academic pursuit, and our intent was to focus the study on clinically important variables such as Hb/ blood loss and need for transfusion. The comment regarding surgical technique and how it may confound the result is an excellent observation. The data analysis included a regression model for which there was no significant difference between surgeons with respect to any of the primary outcomes or postoperative venous thromboembolism prophylaxis used.

your comment on clamping a drain after tranexamic acid has been administered into the hip capsule to prolong its contact with host tissues is an excellent question that is beginning to surface in the literature [4]. Methods and Blinding All patients were evaluated in the preoperative clinic for eligibility. If eligible, they were approached about enrollment by a clinic nurse or resident. If enrolled, they were entered into a randomization table that was held by the institutions research pharmacy. On the day of surgery, each enrolled patient had 3 “medication bags” accompanying them to the operating room from the research pharmacy. Two of these bags were labeled “intravenous tranexamic acid (TXA)-Study Medication” and the other labeled “Topical TXA-Study medication.” As described in the article, the patient was administered either intravenous or topical TXA [5]. Dosage and Timing In an attempt to make the results of this study useful in large academic settings and smaller community settings, the utilization of a pragmatic dosing scheme was used. There have been several studies that demonstrate that using this methodology reduces blood loss and transfusion rate in total joint arthroplasty [4,6-9]. The comment regarding the biphasic nature of the fibrinolytic response after surgery is a well-documented phenomenon. However, with respect to the use of tranexamic acid as a postoperative infusion or as a single dose postoperatively several studies, including Fredin et al have demonstrated that this does not effect calculated blood loss or transfusion requirements [10]. Thank you again for your interest in our article.

Wayne T. North, MD Nima Mehran, MD Jason J. Davis, MD Craig D. Silverton, DO Robb M. Weir, MD Michael W. Laker, MD Department of Adult Reconstructive Surgery Henry Ford Hospital Orthopaedic Surgery Detroit, Michigan

Use of Drains It is not the practice of any of the arthroplasty surgeons at our institution to use drains in primary hip arthroplasty. Although,

Available online xxx

DOI of original article: http://dx.doi.org/10.1016/j.arth.2015.12.002. One or more of the authors of this paper have disclosed potential or pertinent conflicts of interest, which may include receipt of payment, either direct or indirect, institutional support, or association with an entity in the biomedical field which may be perceived to have potential conflict of interest with this work. For full disclosure statements refer to http://dx.doi.org/10.1016/j.arth.2015.12.001. http://dx.doi.org/10.1016/j.arth.2015.12.001 0883-5403/© 2016 Elsevier Inc. All rights reserved.

References 1. Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery 1962;51(2):224.

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Letter to the Editor 2. Lisander B, Ivarsson I, Jacobsson SA. Intraoperative autotransfusion is associated with modest reduction of allogeneic transfusion in prosthetic hip surgery. Acta Anaesthesiol Scand 1998;42(6):707. 3. Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth 2003;90(5):596. 4. Chen JY, Lo NN, Tay DK, et al. Intra-articular administration of tranexamic acid in total hip arthroplasty. J Orthop Surg (Hong Kong) 2015;23(2):213. 5. North W, Mehran N, Davis J, et al. Topical versus intravenous tranexamic acid in primary total hip arthroplasty: a double-blind, randomized controlled trial. J Arthroplasty 2015 [Epub ahead of print]. 6. Jaszczyk M, Kozerawski D, Kolodziej L, et al. Effect of single preoperative dose of tranexamic acid on blood loss and transfusion in hip arthroplasty. Ortop Traumatol Rehabil 2015;17(3):265.

7. Hsu CH, Lin PC, Kuo FC, et al. A regime of two intravenous injections of tranexamic acid reduces blood loss in minimally invasive total hip arthroplasty: a prospective randomised double-blind study. Bone Joint J 2015;97-B(7):905. 8. Xu X, Xiong S, Wang Z, et al. Topical administration of tranexamic acid in total hip arthroplasty: a meta-analysis of Randomized Controlled Trials. Drug Discov Ther 2015;9(3):173. 9. Chang CH, C Y, Chen DW, et al. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res 2014;472(5):1552. 10. Benoni G, Lethagen S, Nilsson P, et al. Tranexamic acid, given at the end of the operation, does not reduce postoperative blood loss in hip arthroplasty. Acta Orthop Scand 2000;71(3):250.