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Ensayo clínico para determinar si el momento de administración del ácido tranexámico en la cirugía de prótesis total de rodilla con torniquete influye en el sangrado perioperatorio
Clinical trial to determine whether the timing of tranexamic acid administration influences perioperative bleeding in total knee arthroplasty
C. Luisa,
Autor para correspondencia
61307@parcdesalutmar.cat

Autor para correspondencia.
, A. Pardoa, C.E. Morenoa, C. Teixella, X. Santiveria, E. Bisbea,b
a Departamento de Anestesiología, Hospital del Mar, Barcelona, España
b Instituto de Investigación Médica Hospital del Mar: IMIM, Barcelona, España
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pr&#243;tesis total de cadera o cirug&#237;a de columna&#46; Tanto la administraci&#243;n intravenosa como la t&#243;pica han demostrado ser efectivas y seguras en la PTR<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">14</span></a>&#46; El efecto antifibrinol&#237;tico y antiinflamatorio del ATX&#44; as&#237; como la mayor&#237;a de los efectos secundarios son dosisdependientes&#46; Cuando se repite la dosis de ATX&#44; esta segunda dosis se suele administrar a las 3<span class="elsevierStyleHsp" style=""></span>h&#44; debido a que esta es la vida media de eliminaci&#243;n del f&#225;rmaco<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">15</span></a>&#46; La dosis y el momento &#243;ptimos para la administraci&#243;n del ATX&#44; as&#237; como tambi&#233;n algunos aspectos de su mecanismo de acci&#243;n y farmacocin&#233;tica&#44; son campos que requieren m&#225;s estudios&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Administrar ATX antes de empezar el procedimiento quir&#250;rgico puede prevenir el inicio de la fibrin&#243;lisis y reducir el sangrado durante la cirug&#237;a<a class="elsevierStyleCrossRefs" href="#bib0185"><span class="elsevierStyleSup">16&#44;17</span></a>&#46; Sin embargo&#44; en la PTR algunos anestesistas prefieren administrar el ATX justo antes de la liberaci&#243;n del torniquete de isquemia&#44; ya que este es el momento de mayor fibrin&#243;lisis y el inicio del sangrado&#46; Adem&#225;s&#44; la administraci&#243;n de ATX al finalizar la cirug&#237;a podr&#237;a reducir el riesgo de trombosis durante el procedimiento y proveer de una hora adicional de efecto antifibrinol&#237;tico postoperatorio&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Revisando la literatura previa solo encontramos un estudio que comparara los diferentes momentos de administraci&#243;n del ATX en la PTR con torniquete&#46; En el grupo que recibi&#243; ATX preoperatorio&#44; el sangrado y los requerimientos de transfusi&#243;n fueron ligeramente menores respecto al grupo que recibi&#243; ATX antes de la liberaci&#243;n del torniquete&#44; aunque no fue de forma significativa<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a>&#46; El n&#250;mero de casos podr&#237;a haber sido insuficiente para mostrar diferencias significativas entre ambos grupos&#46; El mejor momento para la administraci&#243;n de una sola dosis de ATX en la cirug&#237;a de PTR a&#250;n no est&#225; claro y son necesarios m&#225;s estudios&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Por otro lado&#44; algunas publicaciones coinciden en que la administraci&#243;n de 2 dosis de ATX puede ser m&#225;s efectiva que una sola dosis&#46; El estudio mencionado previamente mostr&#243; que administrar 2 dosis de ATX es m&#225;s efectivo&#44; reduciendo el sangrado y manteniendo cifras de hemoglobina &#40;Hb&#41; postoperatorias m&#225;s altas&#46; Sin embargo&#44; las diferencias en los requerimientos transfusionales no fueron significativas<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a>&#46; En otro estudio reciente&#44; el grupo de pacientes que recibi&#243; una sola dosis preoperatoria de ATX tuvo una mayor tasa de transfusi&#243;n respecto al grupo que recibi&#243; 2 dosis &#40;13&#44;5 vs&#46; 5&#44;7&#37; respectivamente&#41;&#44; pero no se encontraron diferencias a nivel del sangrado recogido en drenaje o en la primera Hb postoperatoria&#46; Este estudio presenta importantes limitaciones&#44; ya que se trata de un estudio retrospectivo en el cual las caracter&#237;sticas basales de los pacientes no fueron descritas ni comparadas<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a>&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">El principal objetivo de nuestro estudio es determinar si el momento de la administraci&#243;n del ATX en la PTR con torniquete influye en el sangrado perioperatorio&#44; la transfusi&#243;n sangu&#237;nea o las complicaciones&#46; El objetivo secundario es determinar si una segunda dosis de ATX tiene un impacto cl&#237;nico significativo en los resultados&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Materiales y m&#233;todos</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Dise&#241;o del estudio</span><p id="par0035" class="elsevierStylePara elsevierViewall">El estudio fue aprobado por un Comit&#233; de &#201;tica independiente&#58; CEIC-Parc de Salut MAR &#40;Comit&#233; &#201;tico de Investigaci&#243;n Cl&#237;nica&#44; Parc de Salut MAR&#41;&#44; Barcelona&#44; Espa&#241;a&#44; el 7 de enero de 2016&#46; El ensayo fue registrado en el Registro de ensayos cl&#237;nicos de la uni&#243;n europea &#40;EudraCT 2016-000071-24&#41; y se realiz&#243; de acuerdo con los principios de la Declaraci&#243;n de Helsinki&#46; Se obtuvo el consentimiento informado por escrito de todos los participantes antes de la cirug&#237;a&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">TRANEXTIME es un ensayo cl&#237;nico unic&#233;ntrico&#44; prospectivo&#44; aleatorizado&#44; doble ciego&#44; de 4 grupos paralelos&#44; controlado con placebo&#44; que eval&#250;a la influencia del momento de administraci&#243;n de ATX &#40;previo a la isquemia con torniquete o justo antes de la liberaci&#243;n del torniquete&#41; en la hemorragia perioperatoria en la PTR&#44; y la relevancia cl&#237;nica de una segunda dosis de ATX&#46;</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Poblaci&#243;n incluida</span><p id="par0045" class="elsevierStylePara elsevierViewall">Se incluyeron pacientes adultos mayores de 18 a&#241;os&#44; programados para PTR primaria unilateral y cementada con torniquete&#44; entre abril de 2016 y mayo de 2018 en el Hospital del Mar&#44; y que hubieran firmado el consentimiento informado&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Se excluyeron los pacientes con antecedentes de trombosis arterial o venosa&#44; tromboembolismo pulmonar&#44; fibrilaci&#243;n auricular&#44; enfermedad renal cr&#243;nica &#40;TFG<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>40<span class="elsevierStyleHsp" style=""></span>ml&#47;min&#47;m<span class="elsevierStyleSup">2</span>&#41;&#44; epilepsia &#40;convulsiones en el &#250;ltimo a&#241;o&#41;&#44; trastorno de la coagulaci&#243;n cong&#233;nito o adquirido &#40;incluidos pacientes que toman anticoagulantes o antiagregantes plaquetarios&#41;&#44; alergia o hipersensibilidad al ATX o alguno de los excipientes del medicamento del estudio&#46; Tambi&#233;n se excluyeron las mujeres embarazadas o con posibilidad de estarlo&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">Se dispon&#237;a de un circuito de optimizaci&#243;n de la Hb preoperatoria en la consulta preanest&#233;sica&#44; realizada aproximadamente un mes antes de la cirug&#237;a&#46; Todos los pacientes con anemia &#40;Hb<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>13<span class="elsevierStyleHsp" style=""></span>g&#47;dl&#41; llegaron a la cirug&#237;a con Hb optimizada&#46; La t&#233;cnica anest&#233;sica fue decidida por el anestesi&#243;logo el d&#237;a de la cirug&#237;a&#44; seg&#250;n las caracter&#237;sticas o preferencias del paciente&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">En la sala de recuperaci&#243;n se realiz&#243; un bloqueo ci&#225;tico y femoral para disminuir el dolor postoperatorio&#46; A todos los pacientes se les insert&#243; un drenaje quir&#250;rgico para recolectar el sangrado postoperatorio y se administr&#243; bemiparina profil&#225;ctica diaria &#40;3500<span class="elsevierStyleHsp" style=""></span>mg&#41; para prevenir eventos tromboemb&#243;licos&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">En el momento del estudio&#44; los pacientes ten&#237;an una estancia hospitalaria media de 5 d&#237;as&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Objetivos del estudio</span><p id="par0070" class="elsevierStylePara elsevierViewall">El objetivo principal del estudio fue determinar si en la PTR la administraci&#243;n de ATX tras la inducci&#243;n anest&#233;sica &#40;antes de la isquemia con torniquete&#41;&#44; en lugar de 20-30<span class="elsevierStyleHsp" style=""></span>min antes de la liberaci&#243;n del torniquete&#44; ten&#237;a alg&#250;n efecto sobre el sangrado y los resultados&#46; El estudio se realiz&#243; con ATX intravenoso&#44; por ser la v&#237;a de administraci&#243;n m&#225;s utilizada en nuestro hospital&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">El objetivo secundario fue evaluar el impacto cl&#237;nico de una segunda dosis de ATX &#40;3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s de la cirug&#237;a&#41; sobre los resultados &#40;hemorragia&#44; Hb&#44; transfusi&#243;n de sangre alog&#233;nica y complicaciones&#41;&#46;</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Objetivos</span><p id="par0080" class="elsevierStylePara elsevierViewall">La variable principal fue el sangrado postoperatorio medido en mililitros &#40;ml&#41;&#46; El sangrado postoperatorio se midi&#243; evaluando la p&#233;rdida de sangre visible &#40;cantidad total de sangre en el drenaje hasta la extracci&#243;n&#41; y se calcul&#243; la p&#233;rdida total de sangre utilizando la f&#243;rmula de Gross&#58; p&#233;rdida de eritrocitos no compensada<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>volumen de sangre total &#40;ml&#41;<span class="elsevierStyleHsp" style=""></span>&#215;<span class="elsevierStyleHsp" style=""></span>&#40;hematocrito preoperatorio &#91;HCT&#93;<span class="elsevierStyleHsp" style=""></span>&#8722;<span class="elsevierStyleHsp" style=""></span>HCT en el tercer d&#237;a postoperatorio&#41;&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">Las variables secundarias incluyeron la variaci&#243;n de la Hb&#44; la incidencia de tromboembolismo venoso y embolia pulmonar &#40;solo se registraron episodios cl&#237;nicamente relevantes&#41;&#44; infarto de miocardio&#44; accidente isqu&#233;mico transitorio&#44; ictus isqu&#233;mico y la tasa de transfusi&#243;n sangu&#237;nea perioperatoria&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">Otras variables de este estudio incluyeron&#58; edad&#44; sexo&#44; peso&#44; &#237;ndice de riesgo anest&#233;sico de la Sociedad Americana de Anestesi&#243;logos &#40;ASA&#41;&#44; &#237;ndice de masa corporal&#44; comorbilidades&#44; uso de medicaci&#243;n que afecta el sangrado &#40;agentes antiplaquetarios&#44; anticoagulantes&#44; antidepresivos&#41;&#44; cambios de Hb&#58; preoperatorio &#40;un mes antes de la cirug&#237;a&#41;&#44; preoperatorio inmediato &#40;el d&#237;a de la cirug&#237;a&#41;&#44; 3 d&#237;as despu&#233;s de la cirug&#237;a y al alta&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Aleatorizaci&#243;n y enmascaramiento</span><p id="par0095" class="elsevierStylePara elsevierViewall">Los pacientes fueron seleccionados por el anestesi&#243;logo unos 30 d&#237;as antes de la cirug&#237;a&#44; durante la evaluaci&#243;n preoperatoria&#44; y fueron asignados al azar a uno de los 4 grupos de tratamiento &#40;a trav&#233;s de una lista de aleatorizaci&#243;n 1&#58; 1 de 20 en 20&#41; el d&#237;a anterior a la intervenci&#243;n&#46; Todos los investigadores cl&#237;nicos desconoc&#237;an la asignaci&#243;n de tratamientos&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">El Departamento de Farmacia preparaba 3 viales de soluci&#243;n salina normal &#40;SS&#41; de 100<span class="elsevierStyleHsp" style=""></span>ml por paciente&#59; uno con ATX 15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span>&#44; otro con ATX 10<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> y el otro sin el f&#225;rmaco&#46; Dado que el f&#225;rmaco es transparente&#44; la ampolla de ATX de 5<span class="elsevierStyleHsp" style=""></span>ml se diluy&#243; en 100<span class="elsevierStyleHsp" style=""></span>ml de SS&#44; por lo que el f&#225;rmaco quedaba oculto al personal y al paciente &#40;doble ciego&#41;&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">As&#237;&#44; el primer y segundo vial administrado pod&#237;an contener SS sola o una dosis diluida de ATX&#44; seg&#250;n peso &#40;15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span>&#41;&#44; dependiendo del grupo asignado por aleatorizaci&#243;n&#46; El tercer vial pod&#237;a contener solo SS o ATX 10<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> a&#241;adido&#44; seg&#250;n aleatorizaci&#243;n&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">El primer grupo &#40;grupo 1&#41; recibi&#243; una dosis de ATX 15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 20-30<span class="elsevierStyleHsp" style=""></span>min antes del inicio de la isquemia con torniquete&#44; SS sin ATX antes de la liberaci&#243;n del torniquete y un vial de SS 3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s del final de la cirug&#237;a&#44; en el &#225;rea de reanimaci&#243;n posquir&#250;rgica &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0115" class="elsevierStylePara elsevierViewall">El segundo grupo &#40;grupo 2&#41; recibi&#243; una primera dosis de ATX 15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 20-30<span class="elsevierStyleHsp" style=""></span>min antes del inicio de la isquemia con torniquete&#44; SS sin ATX antes de la liberaci&#243;n del torniquete y una segunda dosis de ATX 10<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s cirug&#237;a&#44; en el &#225;rea de reanimaci&#243;n posquir&#250;rgica&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">El tercer grupo &#40;grupo 3&#41; recibi&#243; un vial de SS sin ATX antes del inicio de la isquemia con torniquete&#44; un vial con ATX 15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 20-30<span class="elsevierStyleHsp" style=""></span>min antes de la liberaci&#243;n del torniquete y un tercer vial de SS sin ATX 3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s de la cirug&#237;a&#44; en el &#225;rea de reanimaci&#243;n posquir&#250;rgica&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">El cuarto grupo &#40;grupo 4&#41; recibi&#243; un vial de SS sin ATX antes del inicio de la isquemia con torniquete&#44; un vial con ATX 15<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 20-30<span class="elsevierStyleHsp" style=""></span>minutos antes de la liberaci&#243;n del torniquete y un tercer vial &#40;2&#46;<span class="elsevierStyleSup">a</span> dosis&#41; de ATX 10<span class="elsevierStyleHsp" style=""></span>mg kg<span class="elsevierStyleSup">-1</span> 3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s de la cirug&#237;a en reanimaci&#243;n posquir&#250;rgica&#46;</p><p id="par0130" class="elsevierStylePara elsevierViewall">Se realizaron 2 cohortes&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">-</span><p id="par0135" class="elsevierStylePara elsevierViewall">Seg&#250;n el momento en que se administr&#243; ATX&#58; antes del inicio de la isquemia &#171;preinducci&#243;n&#187; &#40;grupos 1 y 2&#41; o antes de la liberaci&#243;n del torniquete &#171;preliberaci&#243;n&#187; &#40;grupos 3 y 4&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">-</span><p id="par0140" class="elsevierStylePara elsevierViewall">Seg&#250;n n&#250;mero de dosis ATX recibidas&#58; una sola dosis intraoperatoria &#171;dosis &#250;nica&#187;&#58; &#40;grupos 1 y 3&#41; frente a los grupos que recibieron una segunda dosis postoperatoria &#171;dosis doble&#187; &#40;grupos 2 y 4&#41;&#46;</p></li></ul></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">An&#225;lisis estad&#237;stico</span><p id="par0145" class="elsevierStylePara elsevierViewall">El tama&#241;o de la muestra se calcul&#243; basado en las posibles diferencias en el sangrado &#40;en ml&#41; por drenaje entre los grupos&#46; Aceptando un riesgo alfa de 0&#44;05 y un riesgo beta de 0&#44;2 en una prueba bilateral&#44; eran necesarios 40 sujetos en el primer grupo y 40 en el segundo grupo para identificar una diferencia estad&#237;sticamente significativa<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>100<span class="elsevierStyleHsp" style=""></span>ml&#46; Se asumi&#243; que la desviaci&#243;n est&#225;ndar com&#250;n era de 150<span class="elsevierStyleHsp" style=""></span>ml&#46; Se previ&#243; una tasa de abandono del 10&#37;&#46;</p><p id="par0150" class="elsevierStylePara elsevierViewall">Para el an&#225;lisis descriptivo y ver si hab&#237;a diferencias estad&#237;sticas entre grupos&#44; utilizamos el software SSPS v13&#46; Para comparar los resultados entre grupos&#44; realizamos la t de Student&#44; &#967;<span class="elsevierStyleSup">2</span> y la prueba exacta de Fisher&#44; seg&#250;n se requiriera&#46; Utilizamos la prueba de Levene para detectar la normalidad del par&#225;metro y aplicar una prueba no param&#233;trica&#46; Se consider&#243; estad&#237;sticamente significativo un valor de p<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;05&#46;</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Resultados</span><p id="par0155" class="elsevierStylePara elsevierViewall">Un total de 238 pacientes programados para PTR fueron evaluados en la visita preanest&#233;sica desde abril de 2016 a mayo de 2018&#46; De estos&#44; 26 fueron excluidos previo a la aleatorizaci&#243;n&#44; porque no cumpl&#237;an los criterios de inclusi&#243;n&#46; Otros fueron derivados a otro centro quir&#250;rgico o la cirug&#237;a fue pospuesta&#47;cancelada por motivos ajenos al estudio&#46;</p><p id="par0160" class="elsevierStylePara elsevierViewall">Los 212 pacientes restantes fueron aleatorizados en 4 grupos &#40;grupo 1&#44; grupo 2&#44; grupo 3 y grupo 4&#44; como se ha comentado previamente&#41;&#46; El ensayo finaliz&#243; cuando se hab&#237;a alcanzado el tama&#241;o muestral predeterminado&#46; Un total de 32 pacientes se tuvieron que excluir del estudio el d&#237;a de la cirug&#237;a debido a que los viales preparados por el Departamento de Farmacia no llegaron a tiempo al quir&#243;fano&#44; otros por faltar algunos datos sobre administraci&#243;n de los viales &#40;9 pacientes del grupo 1&#59; 12 del grupo 2&#59; 2 en el grupo 3 y 11 del grupo 4&#41;&#46; Otros 2 pacientes del grupo 3 fueron excluidos del an&#225;lisis estad&#237;stico porque no se hab&#237;a realizado el hemograma postoperatorio y no pod&#237;a hacerse el c&#225;lculo del sangrado&#46; Finalmente&#44; 176 pacientes fueron analizados &#40;44 en el grupo 1&#44; 41 en el grupo 2&#44; 49 en el grupo 3 y 42 en el grupo 4&#41; &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0165" class="elsevierStylePara elsevierViewall">A excepci&#243;n de la edad&#44; las caracter&#237;sticas demogr&#225;ficas y preoperatorias fueron similares en todos los grupos &#40;<a class="elsevierStyleCrossRef" href="#tbl0010">tabla 2</a>&#41;&#46; Se objetiv&#243; una diferencia estad&#237;sticamente significativa del grupo 1 con respecto a la edad&#44; ya que el azar incluy&#243; a pacientes ligeramente mayores&#44; en comparaci&#243;n con los otros grupos&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0170" class="elsevierStylePara elsevierViewall">No hubo diferencias en las caracter&#237;sticas basales entre las cohortes &#171;preinducci&#243;n&#187; y &#171;preliberaci&#243;n&#187;&#44; pero s&#237; en la cohorte seg&#250;n las dosis de ATX recibidas&#44; ya que la Hb y el HTC preoperatorios en el grupo de &#171;dosis doble&#187; fueron significativamente m&#225;s altas que en el grupo &#171;dosis &#250;nica&#187; &#40;<a class="elsevierStyleCrossRef" href="#tbl0015">tabla 3</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Objetivo principal</span><p id="par0175" class="elsevierStylePara elsevierViewall">La administraci&#243;n de ATX en la inducci&#243;n &#40;previo al torniquete&#41; no demostr&#243; diferencias estad&#237;sticamente significativas en el sangrado postoperatorio &#40;visible y calculado&#41; en comparaci&#243;n con la administraci&#243;n previa a la liberaci&#243;n del torniquete &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0020"></elsevierMultimedia><p id="par0180" class="elsevierStylePara elsevierViewall">Tampoco se encontraron diferencias en la Hb postoperatoria&#44; los eventos adversos o las complicaciones&#44; aunque hubo mayor n&#250;mero de hematomas en la rodilla &#40;12 casos vs&#46; 6&#41;&#44; casi significativo&#44; en el grupo &#171;preinducci&#243;n&#187; &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#44; aunque no se observ&#243; mayor anemia postoperatoria&#46;</p><p id="par0185" class="elsevierStylePara elsevierViewall">La tasa de eventos tromboemb&#243;licos fue muy baja&#44; con un solo caso de embolismo pulmonar que tuvo lugar en el grupo &#171;preliberaci&#243;n&#187;&#46; El paciente&#44; un hombre de 70 a&#241;os&#44; present&#243; en el segundo d&#237;a postoperatorio disnea aguda e hipoxemia &#40;desaturaci&#243;n hasta 88&#37; por pulsioximetr&#237;a&#41; secundaria a tromboembolismo segmentario asociado trombosis venosa profunda&#46; El paciente se recuper&#243; &#237;ntegramente tras anticoagulaci&#243;n con enoxaparina y oxigenoterapia suplementaria&#44; sin soporte ventilatorio &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Objetivos secundarios</span><p id="par0190" class="elsevierStylePara elsevierViewall">No se objetivaron diferencias en el sangrado visible ni calculado entre el grupo de &#171;dosis &#250;nica&#187; y el grupo de &#171;doble dosis&#187;&#46;</p><p id="par0195" class="elsevierStylePara elsevierViewall">Sin embargo&#44; destaca que hubo diferencias significativas entre la Hb y el HTC a las 24<span class="elsevierStyleHsp" style=""></span>h poscirug&#237;a y al alta&#44; que podr&#237;an explicarse debido a que tambi&#233;n existen diferencias en la Hb y el HTC preoperatorios &#40;siendo estos valores m&#225;s elevados en el grupo de &#171;doble dosis&#187;&#41;&#46;</p><p id="par0200" class="elsevierStylePara elsevierViewall">Con relaci&#243;n a los eventos adversos intrahospitalarios&#44; la &#250;nica diferencia estad&#237;sticamente significativa fue una mayor tasa de n&#225;useas y v&#243;mitos postoperatoria &#40;4 veces m&#225;s frecuente&#41; en el grupo de dosis &#250;nica&#44; que se correlacion&#243; con un mayor n&#250;mero de episodios de hipotensi&#243;n arterial &#40;no significativo&#41; en ese &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p><p id="par0205" class="elsevierStylePara elsevierViewall">No hubo diferencias en las complicaciones postoperatorias entre los grupos&#44; aunque la incidencia de hematoma postoperatorio tendi&#243; a ser ligeramente m&#225;s elevada en el grupo en el que se administr&#243; una sola dosis de ATX&#46;</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Transfusi&#243;n</span><p id="par0210" class="elsevierStylePara elsevierViewall">Debido a la implementaci&#243;n de un programa de <span class="elsevierStyleItalic">Patient Blood Management</span> &#40;ahorro de sangre&#41; con optimizaci&#243;n de la anemia en la visita preanest&#233;sica&#44; la tasa de transfusi&#243;n en nuestro centro es actualmente muy baja&#46; Solamente un paciente del estudio recibi&#243; una transfusi&#243;n sangu&#237;nea en el postoperatorio &#40;del grupo &#171;preliberaci&#243;n&#187;&#41;&#46;</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Estancia hospitalaria</span><p id="par0215" class="elsevierStylePara elsevierViewall">Ni el momento de administraci&#243;n de ATX ni la administraci&#243;n de una segunda dosis de ATX en el postoperatorio supusieron una reducci&#243;n significativa en la estancia hospitalaria&#46;</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Eventos adversos no relacionados con el ATX</span><p id="par0220" class="elsevierStylePara elsevierViewall">Un paciente en el grupo &#171;preliberaci&#243;n&#187; sufri&#243; una angina de pecho con descenso del segmento ST en las derivaciones precordiales V4-V5 debido a una crisis hipertensiva tras la cementaci&#243;n de la artroplastia de rodilla&#46; Tras 2<span class="elsevierStyleHsp" style=""></span>h de cirug&#237;a&#44; las alteraciones electrocardiogr&#225;ficas desaparecieron y el paciente no present&#243; inestabilidad hemodin&#225;mica ni tampoco elevaci&#243;n de marcadores de lesi&#243;n mioc&#225;rdica&#46;</p><p id="par0225" class="elsevierStylePara elsevierViewall">Otro paciente en el grupo &#171;preliberaci&#243;n&#187; present&#243; una arritmia supraventricular intraoperatoria &#40;fibrilaci&#243;n auricular de novo&#41;&#46;</p><p id="par0230" class="elsevierStylePara elsevierViewall">En el grupo &#171;preinducci&#243;n&#187; un paciente con historia de s&#237;ncopes vasovagales experiment&#243; un cuadro vasovagal en el &#225;rea de recuperaci&#243;n postanest&#233;sica&#44; con bradicardia extrema y asistolia que requiri&#243; de reanimaci&#243;n cardiopulmonar durante 60<span class="elsevierStyleHsp" style=""></span>s y 1<span class="elsevierStyleHsp" style=""></span>mg de adrenalina intravenosa&#46; El paciente se recuper&#243; del episodio sin secuelas &#40;<a class="elsevierStyleCrossRef" href="#tbl0020">tabla 4</a>&#41;&#46;</p></span></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Discusi&#243;n</span><p id="par0235" class="elsevierStylePara elsevierViewall">No encontramos diferencias significativas en el sangrado postoperatorio o en la transfusi&#243;n con relaci&#243;n al momento de administraci&#243;n de ATX en los pacientes operados de PTR&#46; Aunque el sangrado visible y calculado fueron discretamente menores en el grupo que recibi&#243; el ATX previo a la insuflaci&#243;n del torniquete que previo a la liberaci&#243;n de este&#44; la diferencia no fue estad&#237;sticamente significativa&#46; Tampoco hubo diferencias significativas en la Hb a las 24<span class="elsevierStyleHsp" style=""></span>h ni al alta&#44; as&#237; como en la tasa de transfusi&#243;n&#46;</p><p id="par0240" class="elsevierStylePara elsevierViewall">De acuerdo con nuestros resultados podemos concluir que el momento de la administraci&#243;n del ATX en la PTR no tiene relevancia cl&#237;nica&#46;</p><p id="par0245" class="elsevierStylePara elsevierViewall">Nuestros resultados fueron consistentes con el &#250;nico estudio que encontramos con el mismo objetivo&#46; Si bien los autores encontraron una ligera ventaja&#44; en cuanto al sangrado &#40;visible y calculado&#41; en la administraci&#243;n del ATX tras la inducci&#243;n de la anestesia&#44; la diferencia no fue cl&#237;nicamente relevante<a class="elsevierStyleCrossRef" href="#bib0195"><span class="elsevierStyleSup">18</span></a>&#46; Conclu&#237;an que posiblemente un ensayo cl&#237;nico con una muestra m&#225;s grande permitir&#237;a encontrar diferencias relevantes en el sangrado&#44; pero nuestros resultados con el doble de pacientes tampoco muestran impacto cl&#237;nico&#46;</p><p id="par0250" class="elsevierStylePara elsevierViewall">En nuestro estudio&#44; la Hb y el HCT al alta fueron significativamente mayores en los pacientes que recibieron 2 dosis de ATX&#44; pero estas diferencias podr&#237;an atribuirse al hecho de que estos ten&#237;an niveles de Hb y HCT preoperatorios m&#225;s altos&#46;</p><p id="par0255" class="elsevierStylePara elsevierViewall">Como en el estudio de Tanaka&#44; tampoco hubo diferencias en los requisitos de transfusionales&#44; sin embargo&#44; nuestra tasa transfusional es muy baja &#40;un caso&#41; por lo que es imposible observar diferencias significativas&#46; Contrariamente&#44; en el estudio de Legnani et al&#46;<a class="elsevierStyleCrossRef" href="#bib0200"><span class="elsevierStyleSup">19</span></a> con tasas transfusionales del 10&#37;&#44; s&#237; se encontraron diferencias significativas en la transfusi&#243;n &#40;13&#44;5&#37; con una dosis vs&#46; 5&#44;7&#37; con 2 dosis&#41;&#46;</p><p id="par0260" class="elsevierStylePara elsevierViewall">La raz&#243;n de que nuestra tasa de transfusi&#243;n sea muy baja se debe&#44; probablemente&#44; a que todos los pacientes fueron incluidos en el programa <span class="elsevierStyleItalic">Patient Blood Management</span> y llegaron con la Hb preoperatoria optimizada&#44; y a que todos los pacientes recibieron ATX<a class="elsevierStyleCrossRef" href="#bib0205"><span class="elsevierStyleSup">20</span></a>&#46;</p><p id="par0265" class="elsevierStylePara elsevierViewall">Pacientes con mayor riesgo transfusional debido a comorbilidad asociada o que acuden a la cirug&#237;a con una Hb preoperatoria baja &#40;sub&#243;ptima&#41; podr&#237;a beneficiarse de esta segunda dosis de ATX&#46;</p><p id="par0270" class="elsevierStylePara elsevierViewall">Solo tuvimos un caso de embolia pulmonar asociada a trombosis venosa profunda en el grupo &#171;preliberaci&#243;n&#187; pero no encontramos diferencias significativas entre grupos&#44; en cuanto a complicaciones tromboemb&#243;licas&#46; Un ensayo cl&#237;nico doble ciego reciente realizado en nuestro centro encontr&#243; que la isquemia inducida por torniquete en la PTR no aumentaba la fibrin&#243;lisis&#44; en comparaci&#243;n con la cirug&#237;a sin torniquete&#46; Tampoco hubo diferencias en los episodios tromboemb&#243;licos entre PTR o pr&#243;tesis total de cadera con o sin ATX<a class="elsevierStyleCrossRef" href="#bib0210"><span class="elsevierStyleSup">21</span></a>&#46;</p><p id="par0275" class="elsevierStylePara elsevierViewall">El hecho de que el uso de torniquetes no parezca aumentar la fibrin&#243;lisis podr&#237;a explicar por qu&#233; el momento en el que se administra ATX &#40;antes o despu&#233;s de la isquemia&#41; no influye en los eventos tromboemb&#243;licos o el sangrado&#46; Sin embargo&#44; se necesitan m&#225;s estudios para confirmar esto&#46;</p><p id="par0280" class="elsevierStylePara elsevierViewall">Una limitaci&#243;n de nuestro estudio es que no realizamos sistem&#225;ticamente pruebas como el eco-Doppler o d&#237;mero D para detectar trombosis venosa profunda no relevante cl&#237;nicamente&#44; o una gammagraf&#237;a pulmonar para detectar una embolia pulmonar inadvertida&#46; Solo se realizaba en aquellos con sospecha de trombosis venosa profunda o tromboembolismo pulmonar&#46;</p></span><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Conclusi&#243;n</span><p id="par0285" class="elsevierStylePara elsevierViewall">El momento de administraci&#243;n de ATX en artroplastia primaria de rodilla con torniquete no tiene influencia sobre el sangrado visible o calculado ni en las complicaciones tromboemb&#243;licas&#46; En nuestro estudio una segunda dosis de ATX no tuvo relevancia cl&#237;nica en los resultados&#46;</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Contribuci&#243;n de los autores</span><p id="par0290" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">-</span><p id="par0295" class="elsevierStylePara elsevierViewall">Carol Luis&#58; Recolecci&#243;n de datos&#44; redacci&#243;n del art&#237;culo&#44; revisi&#243;n bibliogr&#225;fica&#44; interpretaci&#243;n de resultados&#59;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">-</span><p id="par0300" class="elsevierStylePara elsevierViewall">Ana Pardo&#58; Recolecci&#243;n de datos&#44; redacci&#243;n del art&#237;culo&#44; revisi&#243;n bibliogr&#225;fica&#44; gr&#225;ficos y tablas&#59;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">-</span><p id="par0305" class="elsevierStylePara elsevierViewall">Carlos Moreno&#58; Recolecci&#243;n de datos&#44; redacci&#243;n del art&#237;culo&#44; aplicaci&#243;n del protocolo&#59;</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">-</span><p id="par0310" class="elsevierStylePara elsevierViewall">Claudia Teixell&#58; Recolecci&#243;n de datos&#44; redacci&#243;n del art&#237;culo&#44; revisi&#243;n del art&#237;culo&#59;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">-</span><p id="par0315" class="elsevierStylePara elsevierViewall">Xavier Santiveri&#58; An&#225;lisis estad&#237;stico&#44; interpretaci&#243;n de resultados&#59;</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">-</span><p id="par0320" class="elsevierStylePara elsevierViewall">Elvira Bisbe&#58; Dise&#241;o del estudio&#44; reclutamiento de pacientes&#44; interpretaci&#243;n de resultados&#44; revisi&#243;n del art&#237;culo&#46;</p></li></ul></p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Conflicto de intereses</span><p id="par0325" class="elsevierStylePara elsevierViewall">Ninguno&#46;</p></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Financiaci&#243;n</span><p id="par0330" class="elsevierStylePara elsevierViewall">Este trabajo fue financiado por el Hospital del Mar&#44; Barcelona&#44; sin patrocinadores externos&#46;</p></span></span>"
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        "titulo" => "Resumen"
        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Antecedentes y objetivos</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">El momento &#243;ptimo para la administraci&#243;n de &#225;cido tranex&#225;mico en la artroplastia de rodilla con torniquete no est&#225; claro&#46; El objetivo principal de nuestro estudio era demostrar si su administraci&#243;n tras la inducci&#243;n anest&#233;sica reduce el sangrado postoperatorio respecto a administrarlo antes de la liberaci&#243;n del torniquete&#46; Nuestro objetivo secundario era determinar si una segunda dosis reduce significativamente el sangrado&#46;</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Material y m&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Ensayo cl&#237;nico prospectivo con 212 pacientes programados para pr&#243;tesis total de rodilla&#44; aleatorizados en 4 grupos&#46; El &#225;cido tranex&#225;mico se administr&#243; antes de la isquemia en los &#171;grupos preinducci&#243;n&#187; &#40;1 y 2&#41; y justo antes de la liberaci&#243;n del torniquete en los &#171;grupos preliberaci&#243;n&#187; &#40;3 y 4&#41;&#46; Los grupos 2 y 4 recibieron una segunda dosis 3<span class="elsevierStyleHsp" style=""></span>h despu&#233;s&#46; La variable principal fue el sangrado postoperatorio &#40;visible y el calculado&#41;&#46; Las variables secundarias fueron la variaci&#243;n de hemoglobina&#44; complicaciones y transfusi&#243;n&#46;</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">El sangrado total calculado fue 1563<span class="elsevierStyleHsp" style=""></span>ml &#40;IC 95&#37;&#58; 1445-1681&#41; en los grupos preinducci&#243;n frente a 1576<span class="elsevierStyleHsp" style=""></span>ml &#40;IC 95&#37;&#58; 1439-1713&#41; en los preliberaci&#243;n &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;9&#41;&#59; los de dosis &#250;nica sangraron 1579<span class="elsevierStyleHsp" style=""></span>ml &#40;IC 95&#37;&#58; 1452-1706&#41; frente a 1559<span class="elsevierStyleHsp" style=""></span>ml &#40;IC 95&#37;&#58; 1431-1686&#41; en los de 2 dosis &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;82&#41;&#46; La hemoglobina al alta fue 10&#44;4 &#40;IC 95&#37;&#58; 10&#44;2-10&#44;7&#41; con una dosis frente a 10&#44;8<span class="elsevierStyleHsp" style=""></span>g&#47;dl &#40;IC 95&#37;&#58; 10&#44;6-11&#44;1&#41; con 2 dosis &#40;p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;06&#41;&#46;</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">No se detectaron diferencias en sangrado ni transfusi&#243;n dependiendo del momento de administraci&#243;n del &#225;cido tranex&#225;mico&#46; Una segunda dosis tampoco tuvo impacto significativo&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Registro de ensayo cl&#237;nico&#58; EudraCT 2016-000071-24&#46;</p></span>"
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        "titulo" => "Abstract"
        "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Background and objectives</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">The ideal timing of tranexamic acid administration in total knee arthroplasty with tourniquet remains unclear&#46; Our primary objective was to prove if administering it before surgical incision&#44; instead of before releasing the tourniquet&#44; reduces postoperative bleeding&#46; A second objective was to determine whether a second dose reduces post-operative bleeding&#46;</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Material and methods</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">A prospective&#44; double-blind clinical trial was performed on 212 patients scheduled for total knee arthroplasty&#46; They were randomised into 4 groups&#46; Tranexamic acid was administered before the surgical incision in &#8220;pre-induction groups&#8221; &#40;1 and 2&#41;&#44; and just before the tourniquet release in &#8220;pre-release groups&#8221; &#40;3 and 4&#41;&#46; Groups 2 and 4 received a second dose 3<span class="elsevierStyleHsp" style=""></span>hours post-surgery&#46; Main outcome was postoperative bleeding &#40;visible blood loss and calculated total bleeding&#41;&#46; Secondary outcomes were haemoglobin variations&#44; complications and transfusion rate&#46;</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Results</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">The mean calculated total bleeding was 1563<span class="elsevierStyleHsp" style=""></span>ml &#40;95&#37;CI&#58; 1445 to 1681&#41; in preinduction groups versus 1576<span class="elsevierStyleHsp" style=""></span>ml &#40;95&#37;CI&#58; 1439 to 1713&#41; in pre-release groups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;9&#41;&#59; 1579<span class="elsevierStyleHsp" style=""></span>ml &#40;95&#37;CI&#58; 1452 to 1706&#41; in single-dose groups versus 1559<span class="elsevierStyleHsp" style=""></span>ml &#40;95&#37;CI&#58; 1431 to 1686&#41; in double-dose groups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;82&#41;&#46; One patient was transfused&#46; The mean haemoglobin at discharge was 10&#46;4<span class="elsevierStyleHsp" style=""></span>g&#47;dl &#40;95&#37;CI&#58; 10&#46;2 to 10&#46;7&#41; in singledose groups versus 10&#46;8 &#40;95&#37;CI&#58; 10&#46;6 to 11&#46;1&#41; in double-dose groups &#40;<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;06&#41;&#46;</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusions</span><p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">There were no differences in bleeding or transfusion regarding the time of tranexamic acid administration&#46; The second dose had not impact on outcomes&#46;</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Trial registration&#58; EudraCT 2016-000071-24&#46;</p></span>"
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          3 => array:2 [
            "identificador" => "abst0040"
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        "tipo" => "MULTIMEDIATABLA"
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Variable&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Preinducci&#243;nGrupos 1<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>2&#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>85&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Preliberaci&#243;nGrupos 3<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>91&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Dosis &#250;nicaGrupos 1<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>3&#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>93&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Doble dosisGrupos 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>4&#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>83&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Eventos adversos intrahospitalarios&#44; n &#40;&#37;&#41;</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
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Información del artículo
ISSN: 00349356
Idioma original: Español
DOI:10.1016/j.redar.2021.05.025
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