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Original Article
Effect of tranexamic acid administration on bleeding in primary total hip arthroplasty
Efecto de dosis única intravenosa de ácido tranexámico sobre el sangrado en artroplastia total de cadera. Estudio prospectivo, controlado y aleatorizado
A.B. Fernández-Cortiñasa,
Corresponding author
anabelen6k@gmail.com

Corresponding author.
, J.M. Quintáns-Vázqueza, F. Gómez-Suáreza, O. Simón Murilloa, B.R. Sánchez-Lópezb, J.M. Pena-Gracíaa
a Servicio de Cirugía Ortopédica y Traumatología, Hospital COSAGA, Ourense, Spain
b Servicio de Calidad y Estadística, Hospital COSAGA, Ourense, Spain
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which is a synthetic derivative of lysine with a pure antifibrinolytic action&#44;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">1&#8211;7</span></a> are among these&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">There is scientific evidence reported in the literature on the use of tranexamic acid as a means of saving on transfusions in total hip arthroplasty &#40;THA&#41;&#44; due to its efficacy and safety in randomised studies and meta-analysis&#44; but its use to this end remains controversial in Spain&#46;<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">8&#8211;10</span></a> For this reason we have designed this study&#44; with which we have tried to achieve a higher level of evidence for the use of this drug in our specialty&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">The main aim of this study was to examine the effectiveness of tranexamic acid as a method of reducing perioperative bleeding in patients who had undergone primary THA&#46; Our secondary objective was to evaluate how this drug affected homologous blood transfusion needs&#44; and to assess its safety&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materials and methods</span><p id="par0020" class="elsevierStylePara elsevierViewall">A prospective&#44; randomised study was conducted which included 134 consecutive patients&#44; diagnosed with coxarthrosis and who had been treated with THA by 5 surgeons experienced in this surgery&#44; under spinal anaesthesia&#44; in our hospital in 2014&#46; To ensure randomisation&#44; the hospital clinical file number was used&#44; assigned in order of patient entry&#44; with the result that even numbers were assigned to group A and odd numbers to group B&#46; Both groups were paired regarding variables which could affect the study&#44; such as the comorbidity measured by the Charlson index&#44; grade ASA&#44; IMC&#44; age&#44; gender and pre-surgical analytical parameters&#44; including Hb and Hct values&#44; the 2 groups thus being homogenous prior to intervention&#46; The administration of tranexamic acid was performed by the anaesthesia team prior to surgery&#46; No pre-surgical preparation or anaesthesia procedure was performed to try to reduce intraoperative bleeding&#46; Careful surgical technique and haemostasis were employed as was a direct measurement of intraoperative bleeding&#46; The implant model used was the same in all cases &#40;Furlong<span class="elsevierStyleSup">&#174;</span> uncemented prosthesis&#41;&#46; Minimum patient follow-up was 12 months&#46;</p><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Exclusion criteria</span><p id="par0025" class="elsevierStylePara elsevierViewall">The following patients were eliminated from the study&#58; those allergic to TXA&#44; those with liver failure&#44; haematological diseases&#44; retinopathy&#44; cerebrovascular disease&#44; severe ischaemic cardiopathy&#44; severe kidney failure&#44; severe lung failure&#44; INR<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>1&#46;4&#44; coagulopathies&#44; and a background of arterial or venous thromboembolic disease&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Study variables</span><p id="par0030" class="elsevierStylePara elsevierViewall">The sociodemographic variables of the patients were collected &#40;age at the time of surgery&#44; gender&#41;&#44; clinical data &#40;pre and post intervention haemoglobin and haemocrit levels&#44; and 24<span class="elsevierStyleHsp" style=""></span>h later&#44; and number of transfusions used&#41; plus variables inherent to surgery &#40;time in surgery&#44; number of days stay in hospital&#44; amount of blood collected from the post-operative drain in the first 12&#44; 24&#44; and 48<span class="elsevierStyleHsp" style=""></span>h&#41;&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Hospital surgical protocol</span><p id="par0035" class="elsevierStylePara elsevierViewall">A modified Hardinge lateral or posterior hip approach was performed depending on the surgeon&#39;s preference&#46; In all cases&#44; on completion of surgery&#44; a drain was connected under sterile conditions with which the amount of blood collected in the first 12&#44; 24&#44; and 48<span class="elsevierStyleHsp" style=""></span>h was measured&#44; and the drain was then removed&#46; After the intervention&#44; the patients were moved to the recovery room&#44; and were taken to the ward 3&#8211;4<span class="elsevierStyleHsp" style=""></span>h later&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Surgery was performed under antibiotic prophylaxis with intravenous cefazolin with a pre-surgical dose of 2<span class="elsevierStyleHsp" style=""></span>g&#44; administered 30<span class="elsevierStyleHsp" style=""></span>min prior to intervention and the same administered after surgery with a 1<span class="elsevierStyleHsp" style=""></span>g dose every 8<span class="elsevierStyleHsp" style=""></span>h &#40;3 post-surgical doses&#41;&#46; When the patient was allergic to penicillin they were administered intravenous clindamycin at a pre-surgical dose of 600<span class="elsevierStyleHsp" style=""></span>mg &#40;30<span class="elsevierStyleHsp" style=""></span>min before intervention&#41; a post-surgical dose of 600<span class="elsevierStyleHsp" style=""></span>mg&#47;every 8<span class="elsevierStyleHsp" style=""></span>h &#40;3 post-surgical doses&#41;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">All patients received thromboprophylaxis with a dose of low molecular weight &#40;sodium enoxaparin &#91;40<span class="elsevierStyleHsp" style=""></span>mg&#59; 0&#46;4<span class="elsevierStyleHsp" style=""></span>ml or 4000<span class="elsevierStyleHsp" style=""></span>UI of Clexane<span class="elsevierStyleSup">&#174;</span>&#93;&#41; 12<span class="elsevierStyleHsp" style=""></span>h before surgery and another dose 6<span class="elsevierStyleHsp" style=""></span>h after surgery&#46; It was then administered in a single dose every 24<span class="elsevierStyleHsp" style=""></span>h up to one month after surgery&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">The patient cohort with TXA were administered an intravenous dose of 15<span class="elsevierStyleHsp" style=""></span>mg&#47;kg of TXA &#40;Anchafibrin<span class="elsevierStyleSup">&#174;</span>&#44; Rottapharm&#41; in 100<span class="elsevierStyleHsp" style=""></span>ml of saline solution 15<span class="elsevierStyleHsp" style=""></span>min before surgery&#44; whilst the control group received 100<span class="elsevierStyleHsp" style=""></span>ml of saline solution 15<span class="elsevierStyleHsp" style=""></span>min prior to surgery&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Minimum pre-surgical Hb levels were established at 10<span class="elsevierStyleHsp" style=""></span>g&#47;dl&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Transfusion criteria were based on the clinical practice guidelines recommended by the <span class="elsevierStyleItalic">American Association of Blood Banks&#46;</span><a class="elsevierStyleCrossRefs" href="#bib0200"><span class="elsevierStyleSup">11&#8211;14</span></a> The patients were transfused when postoperative Hb levels&#44; measured 24<span class="elsevierStyleHsp" style=""></span>h after surgery&#44; were below 8<span class="elsevierStyleHsp" style=""></span>g&#47;dl in patients with no previous heart disease and who were asymptomatic or below 9<span class="elsevierStyleHsp" style=""></span>g&#47;dl if the patient presented with a background of cardio respiratory disease or clinical signs during the immediate postoperative period&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Control of possible adverse effects such as deep vein thrombosis &#40;DVT&#41; was carried out with clinical follow-up&#44; and a Doppler ultrasound was only used in cases where clinical suspicion was present&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Ethical aspects</span><p id="par0070" class="elsevierStylePara elsevierViewall">This study was approved by the regional ethical committee and informed consent from all patients in the study was obtained&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Statistical analysis</span><p id="par0075" class="elsevierStylePara elsevierViewall">Initially a descriptive statistical analysis was conducted where qualitative variables were expressed as frequency and percentage&#46; Gaussian continuous variables were expressed as mean<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>standard deviation and non-Guassian variables as median &#40;minimum&#8211;maximum&#41;&#46; Kolmogorov&#8211;Smirnov tests were used to find out the normality of variables&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Parametric&#47;non parametric tests were carried out to determine the potential association between study variables &#40;Chi-square&#44; Student&#39;s <span class="elsevierStyleItalic">t</span>-test&#44; Mann&#8211;Whitney <span class="elsevierStyleItalic">U</span> test&#41;&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Differences of <span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;05 was considered statistically significant in all analysis&#46; The statistical programmes SPSS 22&#46;0 and Epidat 4&#46;1 were used for analysis&#46;</p></span></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Results</span><p id="par0090" class="elsevierStylePara elsevierViewall">Out of the 134 patients who underwent surgery&#44; 67 received treatment with TXA&#46; Of the total patients included in the study 75 were women&#44; which accounted for 66&#37;&#44; with a mean age of 3&#46;26 years older than the men&#46; Presurgical Hb and Hct levels were similar in both groups&#46; In the group which received TXA an Hb level of 1422 and a Hct level of 41&#46;99 was present whilst in the control group the levels were Hb 13&#46;97 and Hct 41&#46;34 &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0095" class="elsevierStylePara elsevierViewall">Time in surgery and hospital stay days were also similar in both groups &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0100" class="elsevierStylePara elsevierViewall">During the first 48<span class="elsevierStyleHsp" style=""></span>h after surgery&#44; levels of bleeding from drains in the control group were higher &#40;660<span class="elsevierStyleHsp" style=""></span>cc&#41; than those in patients treated with TXA &#40;550<span class="elsevierStyleHsp" style=""></span>cc&#41; &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;101&#41;&#44; although the differences were only statistically significant &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;01&#41; compared with levels collected by draining after 24<span class="elsevierStyleHsp" style=""></span>h &#40;400<span class="elsevierStyleHsp" style=""></span>cc in the group treated with TXA compared with 550 of the control group&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> and <a class="elsevierStyleCrossRef" href="#fig0005">Fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0105" class="elsevierStylePara elsevierViewall">Post-surgical Hb and Hct levels were statistically lower &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41; in the control group &#40;Hb &#91;9&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;24&#93; and Hct &#91;27&#46;42<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>4&#46;84&#93;&#41; compared with the group treated with TXA &#40;Hb &#91;11&#46;82<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;45&#93; and Hct &#91;31&#46;55<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>5&#46;02&#93;&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0010">Fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">Statistically significant differences were found &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41; regarding the need for transfusion and the group to which the patients belonged&#46; Out of 134 patients who required transfusion 20 &#40;14&#46;9&#37;&#41;&#44; 17 of them &#40;85&#37;&#41; were patients belonging to the control group&#46; The transfusion percentage per group was 7&#37; in the group treated with TXA and 25&#46;37&#37; in the control group&#44; which constitutes a difference of 20&#46;9 percentage points &#40;<a class="elsevierStyleCrossRef" href="#fig0015">Fig&#46; 3</a>&#41;&#46;</p><elsevierMultimedia ident="fig0015"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">There were no thromboembolic events in any of the groups&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Discussion</span><p id="par0120" class="elsevierStylePara elsevierViewall">The essential findings from this study were that the administration of TXA reduces postoperative bleeding&#44; especially in non-visible losses&#44; and transfusion requirements of patients who have undergone total hip arthroplasty&#46; It equally proves to be a safe procedure&#44; as there is no complication regarding its administration&#46; This is the first article published in Spain in which the use and usage complications of TXA in THA have been studied prospectively&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">Our findings concur with those reported in the literature to date&#46; In the last 5 years 5 meta-analyses have been published on the use of TXA in THA&#44;<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">15&#8211;19</span></a> 2 of them include joint procedures of THA and ATR<a class="elsevierStyleCrossRefs" href="#bib0230"><span class="elsevierStyleSup">17&#44;18</span></a> and the other 3 focus on THA&#46;<a class="elsevierStyleCrossRefs" href="#bib0220"><span class="elsevierStyleSup">15&#44;16&#44;19</span></a> Of the meta-analyses that of Moskal et al&#46;<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">15</span></a> is of note&#44; published in 2016&#44; and which analyses the effects of intravenous administration of TXA in patients who had undergone THA in 16 studies&#44; all of them prospective&#44; randomised and controlled&#46; An analysis of 993 surgical interventions was therefore made&#46; This work concluded that the patients treated with TXA bled less and received fewer transfusions than the control group&#46; Other publications such as the Seville Document and the Guidelines from the European Society of Anaesthesiology<a class="elsevierStyleCrossRefs" href="#bib0245"><span class="elsevierStyleSup">20&#8211;22</span></a> suggested the use of TXA in COT&#44; with a weak recommendation supported by high quality proofs&#46; Furthermore&#44; with regards to ATR about which more publications exist&#44; the American Academy of Orthopaedic Surgeons publishes a practical guide on knee arthrosis with recommendation of TXA use in patients with no known contraindications&#46;<a class="elsevierStyleCrossRef" href="#bib0255"><span class="elsevierStyleSup">22</span></a> Use of TXA in orthopaedic surgery in Spain is increasing&#44; and several articles have been published on its use in the country&#46;<a class="elsevierStyleCrossRef" href="#bib0260"><span class="elsevierStyleSup">23</span></a> The article published by Sanz-Reig et al&#46; in 2014<a class="elsevierStyleCrossRef" href="#bib0265"><span class="elsevierStyleSup">24</span></a> is outstanding in this regard&#46; This was a prospective and randomised study in which the use of TXA in knee replacement surgery was proven to reduce transfusion needs&#46; The latest article published in Spain by Castro et al&#46; &#40;2016&#41; is a prospective and randomised study&#44; although the control group is retrospective&#44; in which the efficacy of the intravenous administration of TXA was studied &#40;on a group with a dose of 1<span class="elsevierStyleHsp" style=""></span>g intraoperatively and 1<span class="elsevierStyleHsp" style=""></span>g 3<span class="elsevierStyleHsp" style=""></span>h after surgery&#46; The other group was administered with 2<span class="elsevierStyleHsp" style=""></span>g intravenously 30<span class="elsevierStyleHsp" style=""></span>min before&#41;&#44; in patients who underwent both ATR and THA&#46;<a class="elsevierStyleCrossRef" href="#bib0190"><span class="elsevierStyleSup">9</span></a></p><p id="par0130" class="elsevierStylePara elsevierViewall">We found no significant increase in complications in the first group treated with TXA compared with the control group&#46; These data coincide with those published in the literature&#44; except with regards to TVP&#44; where there is no consensus due the fact that in several studies&#44; such as the meta-analysis of Moskal et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0220"><span class="elsevierStyleSup">15</span></a> it is clear that there is a greater increase in the TVP rate in patients who received TXA&#44; but in others&#44; however&#44; no differences were found in the cases of TVP&#46;<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">9&#44;24</span></a> For this reason its use in orthopaedic surgery is still controversial&#46; This discordance may be due to the different study sample sizes&#46;</p><p id="par0135" class="elsevierStylePara elsevierViewall">Controversy continues to arise with regards to dose and administration route&#46; Several studies were published last year which compared different guidelines&#44; dose and administration routes&#44; concluding that they were all effective&#44;<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">9&#44;25&#8211;27</span></a> and we thus continue without any conclusive scientific evidence today as to what is the ideal for obtaining maximum benefit with the lowest risk to the patient&#46; With regards to time in surgery&#44; it is notable that in the majority of publications<a class="elsevierStyleCrossRefs" href="#bib0190"><span class="elsevierStyleSup">9&#44;28</span></a> this is not specified&#44; not even if the differences between both groups had been studied according to this parameter&#46; This aspect appears to have an effect on greater intraoperative blood loss&#46; However&#44; although in the present study no direct relationship was found between time in surgery and the need for transfusion&#44; nor in the lowering of post-surgical Hb levels&#44; but there is a trend which was not statistically significant&#46; We must&#44; however&#44; not forget that correct perioperative management includes not only the use of antifibrinolytic drugs but many other factors&#44; including pre-operative calculation of transfusion requirements&#44; individualisation of patient needs&#44; the use of self-recovery drains and correct anaesthetic and surgical techniques and they should be included in a programme to prevent allogenic blood transfusion&#46;<a class="elsevierStyleCrossRefs" href="#bib0245"><span class="elsevierStyleSup">20&#44;22&#44;29</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">There are several limitations to this study&#46; One of them is the sample size &#40;limited to 134 patients&#41;&#46; Secondly&#44; TVP diagnosis was made with clinical follow-up&#44; indicating only Doppler ultrasound in cases in which there was clinical suspicion&#44; which is an attitude that is more similar to daily clinical practice&#44; but no Doppler ultrasound was systematically performed to detect the cases of subclinical TVP&#46; The strong points of this study are that this is a prospective&#44; randomised and controlled study and that the surgical team were stable&#44; as was the nursing team and the laboratory team&#46; Strict written compliance of perioperative protocol and measurements were thus achieved&#44; with no bias of untrained staff present&#46; Surgeries were also consecutive and with very similar demographics&#44; thus constituting homogenous groups&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Conclusion</span><p id="par0145" class="elsevierStylePara elsevierViewall">The administration of TXA has proven to be a safe&#44; effective method for reducing non-visible losses and through drains 24<span class="elsevierStyleHsp" style=""></span>h after patients underwent THA&#46; Transfusion requirements were also lower in the group treated with TXA compared with the control group&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Level of evidence</span><p id="par0150" class="elsevierStylePara elsevierViewall">Level of evidence II&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Ethical disclosures</span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Protection of humans and animal subject</span><p id="par0155" class="elsevierStylePara elsevierViewall">The authors declare that no experiments on humans or animals were involved in this research&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Confidentiality of data</span><p id="par0160" class="elsevierStylePara elsevierViewall">The authors declare they have adhered to the protocols of their centre of work on the publication of patient data&#46;</p></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Right to privacy and informed consent</span><p id="par0165" class="elsevierStylePara elsevierViewall">The authors declare that no patient data appear in this article&#46;</p></span></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conflict of interests</span><p id="par0170" class="elsevierStylePara elsevierViewall">The authors have no conflict of interests to declare&#46;</p></span></span>"
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    "fechaRecibido" => "2016-09-22"
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            0 => "Tranexamic acid"
            1 => "Total hip arthroplasty"
            2 => "Bleeding"
            3 => "Transfusion"
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          "palabras" => array:4 [
            0 => "&#193;cido tranex&#225;mico"
            1 => "Artroplastia total de cadera"
            2 => "Sangrado"
            3 => "Transfusi&#243;n"
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    "resumen" => array:2 [
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objective</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">To study the efficacy of tranexamic acid to decrease perioperative bleeding in patients who have undergone a total hip arthroplasty operation and to evaluate drug safety&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Materials and methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Observational&#44; prospective&#44; controlled and randomised study on the efficacy of tranexamic acid as a method to reduce bleeding in primary hip replacement surgery&#46; We included 134 patients operated during 2014 in our centre&#44; who were divided into 2 groups according to whether or not they had received tranexamic acid&#46; The main study variables were haemoglobin and haematocrit levels&#44; the amount of blood collected from the post-operative drain in the first 12&#44; 24 and 48<span class="elsevierStyleHsp" style=""></span>h and transfusion requirements&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Post-operative haemoglobin and haematocrit levels were statistically higher &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41; in the group with treatment&#46; During the first 48<span class="elsevierStyleHsp" style=""></span>h bleeding values from the group that did not receive TAX were higher compared to patients treated with tranexamic acid&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">Statistically significant differences &#40;<span class="elsevierStyleItalic">p</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#46;001&#41; were found as to the need for transfusion according to group&#44; more transfusions were performed in the cohort that had not received tranexamic acid&#58; 25&#46;37&#37; compared to 4&#46;48&#37; for the group with tranexamic acid&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">No adverse events related to administration of tranexamic acid were recorded&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusion</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Administration of tranexamic acid has proved to be an effective and safe method to reduce peri-operative bleeding in patients who underwent total hip arthroplasty and avoids allogenic blood transfusion&#46; Therefore&#44; tranexamic acid treatment could entail a financial saving for the healthcare system and expose the patient to less risk&#46;</p></span>"
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        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Objetivo</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Estudiar la efectividad del &#225;cido tranex&#225;mico como m&#233;todo para disminuir el sangrado perioperatorio en pacientes intervenidos de artroplastia total primaria de cadera&#44; as&#237; como su seguridad&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Material y m&#233;todos</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Estudio prospectivo&#44; aleatorizado y controlado sobre la eficacia del &#225;cido tranex&#225;mico como m&#233;todo para disminuir el sangrado en cirug&#237;a prot&#233;sica primaria de cadera&#46; Se han incluido 134 pacientes intervenidos durante el a&#241;o 2014 en nuestro centro&#44; los cuales se han dividido en 2 grupos seg&#250;n se le ha administrado o no &#225;cido tranex&#225;mico&#46; Las variables principales del estudio fueron los niveles de hemoglobina y hematocrito posquir&#250;rgicos a las 24<span class="elsevierStyleHsp" style=""></span>horas&#44; la cantidad de sangre recogida en el drenaje postoperatorio a las 12&#44; 24 y 48<span class="elsevierStyleHsp" style=""></span>horas&#44; as&#237; como las necesidades transfusionales&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">Los niveles de hemoglobina y hematocrito posquir&#250;rgicos fueron estad&#237;sticamente superiores &#40;p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41; en el grupo al que se le administr&#243; &#225;cido tranex&#225;mico&#46; En las primeras 48<span class="elsevierStyleHsp" style=""></span>horas los valores de sangrado del grupo control fueron mayores con respecto a los pacientes tratados con &#225;cido tranex&#225;mico&#46;</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Se encontraron diferencias estad&#237;sticamente significativas &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41; en cuanto a la necesidad de transfusi&#243;n en funci&#243;n del grupo&#44; siendo superior en el grupo control &#40;25&#44;37&#37; frente a 4&#44;48&#37; del grupo tratado&#41;&#46;</p><p id="spar0055" class="elsevierStyleSimplePara elsevierViewall">No se registraron eventos adversos relacionados con la administraci&#243;n de &#225;cido tranex&#225;mico&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">La administraci&#243;n de &#225;cido tranex&#225;mico ha demostrado ser un m&#233;todo efectivo y seguro para disminuir el sangrado perioperatorio en pacientes intervenidos de artroplastia total primaria de cadera&#44; y as&#237; disminuir las necesidades transfusionales&#46;</p></span>"
        "secciones" => array:4 [
          0 => array:2 [
            "identificador" => "abst0025"
            "titulo" => "Objetivo"
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          1 => array:2 [
            "identificador" => "abst0030"
            "titulo" => "Material y m&#233;todos"
          ]
          2 => array:2 [
            "identificador" => "abst0035"
            "titulo" => "Resultados"
          ]
          3 => array:2 [
            "identificador" => "abst0040"
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    "NotaPie" => array:1 [
      0 => array:2 [
        "etiqueta" => "&#9734;"
        "nota" => "<p class="elsevierStyleNotepara" id="npar0020">Please cite this article as&#58; Fern&#225;ndez-Corti&#241;as AB&#44; Quint&#225;ns-V&#225;zquez JM&#44; G&#243;mez-Su&#225;rez F&#44; Sim&#243;n Murillo O&#44; S&#225;nchez-L&#243;pez BR&#44; Pena-Grac&#237;a JM&#46; Efecto de dosis &#250;nica intravenosa de &#225;cido tranex&#225;mico sobre el sangrado en artroplastia total de cadera&#46; Estudio prospectivo&#44; controlado y aleatorizado&#46; Rev Esp Cir Ortop Traumatol&#46; 2017&#59;61&#58;289&#8211;295&#46;</p>"
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          "en" => "<p id="spar0065" class="elsevierStyleSimplePara elsevierViewall">Diagram of mean volume of bleeding collected by the drain system depending on the group&#46;</p>"
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                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">71&#46;72<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;38&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">71&#46;6<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;66&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">71&#46;82<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>8&#46;16&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;878&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Gender female n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">75 &#40;56&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">37 &#40;55&#46;2&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">38 &#40;56&#46;7&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;62<a class="elsevierStyleCrossRef" href="#tblfn0010"><span class="elsevierStyleSup">b</span></a>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">14&#46;22<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>1&#46;43&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;310&nbsp;\t\t\t\t\t\t\n
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                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="" valign="top" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Drain 12<span class="elsevierStyleHsp" style=""></span>h &#40;cc&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Drain 24<span class="elsevierStyleHsp" style=""></span>h &#40;cc&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">550 &#91;30&#8211;1380&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;011&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Drain 48<span class="elsevierStyleHsp" style=""></span>h &#40;cc&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">550 &#91;0&#8211;1450&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">660 &#91;40&#8211;1670&#93;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;101&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Post surgical Hb&#43;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">9&#46;07<span class="elsevierStyleHsp" style=""></span>&#177;<span class="elsevierStyleHsp" style=""></span>&#40;1&#46;24&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">&#60;0&#46;001&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">60 &#91;30&#8211;125&#93;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="char" valign="top">0&#46;714&nbsp;\t\t\t\t\t\t\n
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ISSN: 19888856
Original language: English
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