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Efficacy and Safety of Fibrin Glue and Tranexamic Acid to Prevent Postoperative Blood Loss in Total Knee ArthroplastyA Randomized Controlled Clinical Trial
X. Aguilera, MD1; M.J. Martinez-Zapata, MD, PhD2; A. Bosch, MD3; G. Urrútia, MD, MSc, PhD2; J.C. González, MD1; M. Jordan, MD1; I. Gich, MD, MSc, PhD2; R.M. Maymó, BSc3; N. Martínez, BSc3; J.C. Monllau, MD, PhD1; F. Celaya, MD, PhD1; J.A. Fernández, MD1
1 Orthopedic Surgery and Traumatology Department (X.A., J.C.G., M.J., J.C.M., and F.C.) and Anesthesiology Department (J.A.F.), Hospital de la Santa Creu i Sant Pau, Sant Antoni Mª Claret 167, 08025 Barcelona, Spain
2 Iberoamerican Cochrane Centre-Clinical Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Universitat Autónoma de Barcelona, CIBER de Epidemiología y Salud Pública (CIBERESP), IIB Sant Pau, Sant Antoni Mª Claret 171, 08041Barcelona, Spain. E-mail address M.J. Martinez-Zapata: mmartinezz@santpau.cat
3 Blood and Tissue Bank of Catalonia, Passeig Taulat 106-116, 08005 Barcelona, Spain
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Investigation performed at the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

A commentary by Ronald E. Delanois, MD, and Michael A. Mont, MD, is linked to the online version of this article at jbjs.org.



Disclosure: One or more of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of an aspect of this work. None of the authors, or their institution(s), have had any financial relationship, in the thirty-six months prior to submission of this work, with any entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, no author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2013 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2013 Nov 20;95(22):2001-2007. doi: 10.2106/JBJS.L.01182
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Abstract

Background: 

Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome. The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty.

Methods: 

A randomized, single-center, parallel, open clinical trial was performed in adult patients undergoing primary total knee arthroplasty. Patients were divided into four groups. Group 1 received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia, Group 2 received Tissucol (fibrinogen and thrombin), Group 3 received intravenous tranexamic acid, and Group 4 (control) had no treatment other than routine hemostasis. The primary outcome was total blood loss collected in drains after surgery. Secondary outcomes were the calculated hidden blood loss, transfusion rate, preoperative and postoperative hemoglobin, number of blood units transfused, adverse events, and mortality.

Results: 

One hundred and seventy-two patients were included. The mean total blood loss (and standard deviation) collected in drains was 553.9 ± 321.5 mL for Group 1, 567.8 ± 299.3 mL for Group 2, 244.1 ± 223.4 mL for Group 3, and 563.5 ± 269.7 mL for Group 4. In comparison with the control group, Group 3 had significantly lower total blood loss (p < 0.001), but it was not significantly lower in Groups 1 and 2. The overall rate of patients who had a blood transfusion was 21.1% (thirty-five of 166 patients analyzed per protocol). Two patients required transfusion in Group 3 compared with twelve patients in Group 4 (p = 0.015). No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion. There was no difference between groups with regard to the percentage of adverse events.

Conclusions: 

Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements, and we no longer use them. However, this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss.

Level of Evidence: 

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

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    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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